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

Catalog Number	H93863
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the clamps (slide clamps) to close the spike end of each of the three (3) tubes on a trifurcated fluid transfer tube set did not stop the flow of fluids through the tube which resulted in leakage onto the surface of spikes that have not yet been used and seepage of used fluids into other leads and the final filling tube.This was further described as ¿the solution was still running through the line even with clamped ports¿.The issue was identified during a trial testing process on a baxa pump.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured between february 04, 2021 to february 08, 2021.H10: one (1) actual sample and one (1) companion sample was received for evaluation.Visual inspection of both samples did not identify any abnormalities that could have contributed to the reported condition.Functional testing of the inlet clamps on both samples were performed and no defect was observed.Measurements of all slide clamps of both samples was performed and the clamps were determined to be within specifications.The reported condition was not verified.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: TUBE SET, STD VOL, TRIFURC, ST
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt 001 mz 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15108494
• Report Number: 1416980-2022-03859
• Device Sequence Number: 19980484
• Product Code: FPA
• UDI-Device Identifier: 00085412476698
• UDI-Public: (01)00085412476698
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K062909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: 01/31/2024
• Device Catalogue Number: H93863
• Device Lot Number: 60282049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2022
• Supplement Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown