MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	1C8160
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that eight (8) solution sets were leaking from an unspecified location.The leaks were observed during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B3: event date ¿ the leaks with the tubing were observed 8 time since march.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was received for d4 (lot #, expiration date, udi #), h4, h6 and h10.H10: the actual devices were not available; however, ninety-six (96) unused (companion) samples were received for evaluation.A visual inspection was performed on the 96 samples and no defects were observed that could have generated the reported issue.Functional tests which included pressure, slide and roller clamp activation, clear passage, and connect the clamp to tubing cycle tests were performed with no issues noted.A dimensional test was performed on twenty (20) units which found the tubing to be according to specification.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: SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque ind; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18210337
• Report Number: 1416980-2023-06156
• Device Sequence Number: 12605957
• Product Code: FPA
• UDI-Device Identifier: 00085412020594
• UDI-Public: (01)00085412020594
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K203609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2024

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: 06/23/2025
• Device Catalogue Number: 1C8160
• Device Lot Number: R23F23055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2023
• Supplement Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Patient Sex: Unknown