MAUDE Adverse Event Report: BACTISURE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Event Description

Bactisure is a product for use in surgery to remove debris from wounds using pulsed lavage.It is distributed in a 1,000 ml polypropylene plastic bag with a single spike port that resembles commercially prepared intravenous solution bags.This presents potential for the product to inadvertently be administered intravenously.The bag includes the warning statement, "not for iv use"; however, this is a negative warning statement rather than an affirmative statement (e.G., "for wound lavage").When negative warning statements are utilized, practitioners may only see the "iv use" portion of the warning and administer the medication intravenously.The single spike port will accept/connect to infusion tubing currently utilized for commercially prepared intravenous solution bags.The product contains ethanol (a solvent), acetic acid (a ph modifier), sodium acetate (a buffer), and benzalkonium chloride (a surfactant).It is unk at this time the effect these ingredients would have on a pt should the solution be inadvertently administered intravenously.Cross reported to medwatch.(b)(4).

• Brand Name: BACTISURE
• Type of Device: BACTISURE
• MDR Report Key: 6791598
• MDR Text Key: 82684070
• Report Number: MW5071551
• Device Sequence Number: 1
• Product Code: FQH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1