MAUDE Adverse Event Report: BAXTER VIAL MATE ADAPTER; IV TRANSFER SET

Model Number 288071

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2016

Event Type  malfunction  

Event Description

Nurse was reconstituting iv vancomycin with a vial mate adaptor she checked the medication to see if it was mixed and yelled at me that was a gray particle floating in the solution.I gave her 2 more bags which both had a floater from the rubber stopper in the solution.Although the pt did not receive this medication i immediately recalled all of the adapters back into the pharmacy and quarantined them.The antibiotic that was contaminated, was not used.A new vial was reconstituted and used to avoid contamination.

• Brand Name: VIAL MATE ADAPTER
• Type of Device: IV TRANSFER SET
• Manufacturer (Section D): BAXTER; deerfield IL 60015
• MDR Report Key: 5778295
• MDR Text Key: 49135503
• Report Number: MW5063288
• Device Sequence Number: 1
• Product Code: LHI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2017
• Device Model Number: 288071
• Device Lot Number: GR16A27045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 85