B. Braun
B Braun Sterile Water for Irrigation 1000 ml Plastic Irrigation Container
B Braun Sterile Water for Irrigation 1000 ml Plastic Irrigation Container
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Product Overview
B. Braun Sterile Water for Irrigation USP is a clear, colourless, non-pyrogenic aqueous solution presented in a 1000 mL Ecotainer® Plastic Irrigation Container (PIC). The container is constructed without PVC and without DEHP, addressing concerns surrounding plasticiser leaching, environmental waste-stream incineration by-products, and patient exposure to phthalates. The integrated moulded hand-grip and non-drip pour spout reduce splash and accidental contamination during open pouring and bowl-fill techniques in operating-room and procedure-room workflows.
Each 1000 mL bottle is single-patient, single-procedure use; once opened, any unused content must be discarded in accordance with USP <797> and institutional infection-control policy. Sterile Water for Irrigation USP is hypotonic and is contraindicated for intravenous administration; absorption of large volumes during high-pressure surgical irrigation (e.g., transurethral resection) can produce dilutional hyponatraemia and haemolysis, and irrigation pressure and volume must be controlled per surgical protocol.
Specifications
| Manufacturer | B. Braun Medical Inc. |
|---|---|
| Brand / Container | Ecotainer® Plastic Irrigation Container (PIC™) |
| Catalogue / REF | R5000-01 |
| Volume | 1000 mL (1 L) |
| Composition | Sterile Water for Irrigation USP — water for irrigation, no antimicrobial preservatives, no buffering or bacteriostatic agents |
| pH | 5.0–7.0 (typical) |
| Tonicity | Hypotonic (0 mOsmol/L) |
| Sterility | Sterile, non-pyrogenic, single use |
| Container Material | PVC-free, DEHP-free, latex-free polyolefin |
| Latex Content | Latex-free |
| Regulatory | USP monograph compliant; US FDA approved (NDC 0264-7950-00); CE Mark under EU MDR 2017/745; ISO 13485 manufacture; HSA Singapore registered medical device (Class B) |
| Storage | Room temperature 20–25 °C; brief excursions to 40 °C permitted; do not freeze |
| Packaging | 16 bottles per case |
Clinical Indications
- Wound irrigation and debridement of acute and chronic wounds, burns, and surgical incisions
- Open and laparoscopic surgical irrigation where a sterile, non-electrolyte aqueous medium is indicated
- Bladder, urethral, and indwelling-catheter irrigation when a non-pyrogenic, isotonic-sodium-chloride alternative is contraindicated
- Irrigation of ostomies, drains, fistulae, and tracheostomy stomas
- Diluent / reconstitution medium for topical antiseptic and topical pharmaceutical preparations as directed by the prescriber
- Endoscopic and arthroscopic irrigation under controlled-pressure protocols
Frequently Asked Questions
Is the Ecotainer container safe for the OR environment?
Yes. The Ecotainer PIC is manufactured from polyolefin and is PVC-free and DEHP-free, eliminating dioxin precursors generated when PVC waste is incinerated and removing patient exposure to DEHP plasticiser leachate. The non-drip spout and integrated hand-grip are designed for single-handed bowl-pour technique in sterile fields.
Can Sterile Water for Irrigation USP be used intravenously?
No. Sterile Water for Irrigation is hypotonic and is not for intravenous administration. IV use of hypotonic water causes haemolysis. Use 0.9% Sodium Chloride for Injection or another isotonic crystalloid for IV indications.
What is the difference between Sterile Water for Irrigation and 0.9% Sodium Chloride irrigation?
Sterile Water for Irrigation is electrolyte-free and is the irrigant of choice when a non-electrolyte fluid is required (for example, monopolar transurethral resection of the prostate using non-conductive irrigation). 0.9% Sodium Chloride is isotonic and is preferred for routine wound irrigation where electrolyte balance must be preserved.
What is the regulatory status in Singapore?
The product is registered with Singapore's Health Sciences Authority (HSA) under the Medical Devices Act and is supplied to public-sector hospitals, private hospitals, day-surgery centres, and licensed clinics. HSA registration listings are available on the SMDR public register. Essential Medical International Supplies Pte Ltd is the appointed Singapore distributor.
What is the shelf life and storage requirement?
Standard shelf life is 24 months from date of manufacture when stored at controlled room temperature (20–25 °C). Brief excursions to 40 °C are permitted per the product insert. Once a unit is opened, any residual volume must be discarded — Sterile Water for Irrigation USP contains no antimicrobial preservative.
Can the bottle be warmed prior to use?
Yes, within manufacturer limits. Warming cabinets must not exceed 40 °C and the warming time must follow institutional policy. Do not microwave irrigation bottles. Verify temperature of the irrigant prior to use to avoid thermal injury, particularly for arthroscopic and endoscopic procedures.
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