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

Catalog Number 2B8071

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 05/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that four (4) vial-mate adapters were leaking from where the vial connects with the white portion of the vial-mate.This was identified prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d4 lot #, h3, h4 and h6.D4: lot #: the customer reported a suspect lot gr20c06017.H4: the suspect lot was manufactured between april 3, 2020 and april 5, 2020.H10: only two (2) actual samples were received for evaluation (one activated and one in the inactivated position) attached to vials and solution bags.Visual inspection was performed which observed fluid on the outside of the bags.Functional testing was performed for both samples using a new solution bag (returned bags did not have enough solution) and the original vials.The samples functioned as expected with no leaks observed.No additional defects were observed on samples.The reported condition was not verified for the returned samples during functional testing.The remaining two (2) samples were not received for evaluation; therefore, a device analysis could not be completed for those samples.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
• MDR Report Key: 10125337
• MDR Text Key: 194199931
• Report Number: 1416980-2020-03177
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: K142600
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• 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: 05/22/2020
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1