MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. SET, ADMIN, HIGH VOL, 1.2 FLTR, INJ SITE, FS, TOTM 15/BX; ADMINISTRATION INTRAVASCULAR SET

Model Number	21-7361-24
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.(b)(6).A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Investigation still in progress.
Event or Problem Description
It was stated that the tubing disconnected from the luer lock during an ongoing infusion in the tunneled central venous catheter.The event while in use with a patient, with patient harm.
Additional Manufacturer Narrative
One device was received for investigation.The reported issue was confirmed during functional testing when the reported issue was duplicated.The issue was traced to the luer connection, which was determined to be absent of bonding solvent.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.However, the investigation attributed the issue to an error during the manufacturing process.Complaint information will continue to be monitored.

• Brand Name: SET, ADMIN, HIGH VOL, 1.2 FLTR, INJ SITE, FS, TOTM 15/BX
• Common Device Name: ADMINISTRATION INTRAVASCULAR SET
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21612346
• Report Number: 3012307300-2025-02930
• Device Sequence Number: 7695027
• Product Code: FPA
• UDI-Device Identifier: 15019517191738
• UDI-Public: (01)15019517191738(17)281005(10)4434713
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: Health Professional
• Device Model Number: 21-7361-24
• Device Catalogue Number: 21-7361-24
• Device Lot Number: 4434713
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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
• Patient Sex: Unknown