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

Catalog Number	H93863
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/29/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10242815
• Report Number: 1416980-2020-03838
• Device Sequence Number: 2433230
• Product Code: FPA
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K062909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: H93863
• Device Lot Number: 60148524
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1