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

Catalog Number 2B8071

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  malfunction  

Event Description

It was reported that a vial-mate adapter leaked.This was observed during patient infusion with vancomycin hydrochloride.The dose of vancomycin was hung which started to backfill despite being locked, then started to leak between device and vial of medication.The nurse clamped the tubing above the vial-mate to prevent leaking which then allowed the entire medication to be infused.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Lot #: the suspect lot was either gr23b16017 or gr23a19024.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the lot was manufactured from january 30, 2023 to january 31,2023.H10: the actual device was received for evaluation.The device was received inactivated and was connected to a vial and a reconstitution bag.Upon visual inspection of the complaint sample, no defects were detected for the device.The infusion bag was received empty; therefore, no leakage could be observed.A functional test was performed with device activation and no issues were observed.The reported condition was not verified.The device met specifications.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: VIAL-MATE RECONSTITUTION DEVICE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CLEVELAND; 911 highway 61 north; po box 1058; cleveland MS 38732
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16975005
• MDR Text Key: 315836157
• Report Number: 1416980-2023-02475
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

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 Catalogue Number: 2B8071
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Initial Date Manufacturer Received: 04/26/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: 06/08/2023
• Supplement Dates FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 0.9% SODIUM CHLORIDE; VANCOMYCIN HYDROCHLORIDE