MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, TRIFURC, ST; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number H93863

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 04/29/2020

Event Type  malfunction  

Manufacturer Narrative

The user facility submitted a medwatch report for this event: mw5094351.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that six (6) trifurcated fluid transfer tube sets had defective heat seals leading to a loss of sterility.This was identified during an unspecified step.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h4 and h6.H4: the lot was manufactured from september 07, 2018 - september 11, 2018.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The samples were not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: TUBE SET, STD VOL, TRIFURC, ST
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10242815
• MDR Text Key: 197914319
• Report Number: 1416980-2020-03838
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (y/n): Y
• PMA/PMN Number: K062909
• 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: 07/28/2020

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 Expiration Date: 08/31/2021
• Device Catalogue Number: H93863
• Device Lot Number: 60148524
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1