MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. SET, ADMIN, CADD, 60", SPIKE, ASV 12/BX; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7022-24
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no sample was returned for evaluation.Without the return of the samples a comprehensive failure investigation cannot be performed and a probable cause cannot be determined.The device history record of reported lot number was reviewed and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.
Event or Problem Description
It was reported that the tubing was disconnected at a connector because the blue piece that protects it kept popping off.It had been attempted to reconnect the tubing and restart the pump but a "downstream occlusion" alarm was displayed.There was patient involvement and no patient harm/adverse event reported.

• Brand Name: SET, ADMIN, CADD, 60", SPIKE, ASV 12/BX
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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 north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21529677
• Report Number: 9617604-2025-00172
• Device Sequence Number: 13185552
• Product Code: FPA
• UDI-Device Identifier: 10610586019791
• UDI-Public: (01)10610586019791(17)290912(10)6037612
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2025

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 Catalogue Number: 21-7022-24
• Device Lot Number: 6037612
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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