MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VIAL-MATE ADAPTOR; SET, I.V. FLUID TRANSFER

Model Number 2B8071

Device Problems Improper or Incorrect Procedure or Method (2017); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The nurse could not get all of the diluted zosyn 2.25g vial back into the iv bag using the vial-mate adaptor because there was not enough air in the iv bag.The nurses solution to this was to add air to the iv bag (not recommended).Below i have listed all of the specific products that were used.Zosyn 2.25gm vial ndc 60505-6156-0 by apotex corp 0.9% sodium chloride 100ml bag ndc 0338-0049-38 by baxter vial-mate adaptor baxter product 2b8071.Fda safety report id # (b)(4).

• Brand Name: VIAL-MATE ADAPTOR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL 60015
• MDR Report Key: 11870033
• MDR Text Key: 252690542
• Report Number: MW5101502
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2B8071
• Device Catalogue Number: 2B8071
• Device Lot Number: GR21A15024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 68