MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7105-24
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Event or Problem Description
It was reported that there was an occlusion during purging and when igniting the pump once turned off to re-purge.Patient was not relieved immediately because cadd pump was set with a few minutes delay due to occlusion.

• Brand Name: CADD EXTENSION SET
• 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: 23398340
• Report Number: 3012307300-2025-11810
• Device Sequence Number: 10052878
• Product Code: FPA
• UDI-Device Identifier: 10610586022715
• UDI-Public: (01)10610586022715(17)271016(10)4342649
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K942046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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: 21-7105-24
• Device Lot Number: 4342649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2022
• 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