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

Catalog Number	H93863
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that at least one of the three spikes of a trifurcated fluid transfer tube set detached leading to a leak.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
B5: update "during setup and preparation prior to patient use" to "during compounding." h4: lot manufactured between july 11, 2018 to july 12, 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 device was discarded; 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: 10333008
• Report Number: 1416980-2020-04392
• Device Sequence Number: 17009911
• Product Code: FPA
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 06/30/2021
• Device Catalogue Number: H93863
• Device Lot Number: 60137395
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1