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 01/24/2023

Event Type  malfunction  

Event Description

It was reported that two (2) vial-mate reconstitution devices were leaking outside the adapter and solution was backflowing into the vial.The leak was observed during reconstitution.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction made to a1: patient identifier: none (previously submitted as unknown).Correction made to a2-a6: na (previously submitted as ni).Correction made to b5: there was no patient involvement (previously submitted as there was no report of patient injury or medical intervention associated with this event).Correction made to b6: na (previously submitted as ni).Correction made to b7: na (previously submitted as ni).Correction made to d10: na (previously submitted as ni).Correction made to f10/h6: health effect - impact codes: replace f26 with f27.H10: the devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.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: 17321766
• MDR Text Key: 319228197
• Report Number: 1416980-2023-03552
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

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: Other
• Device Catalogue Number: 2B8071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: No
• 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