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

Catalog Number	21-7324-24
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the tubing is placed on the pump, everything is alright, then validation of the parameters is alright, the start of the purge is alright, then after 2 minutes the pump rings and the alarms detect an occlusion.The reported issue occurred just before use with the patient.No clinical consequences except that the patient did not have the optimal analgesia.The pump was changed.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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 device fluid path, which was determined to have excessive 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.The investigation attributed the excess solvent to an error during the manufacturing process.Complaint information will continue to be monitored.

• Brand Name: CADD ADMINISTRATION 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21304732
• Report Number: 3012307300-2025-01482
• Device Sequence Number: 8848104
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: (01)10610586029653(17)290717(10)6026729
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 21-7324-24
• Device Lot Number: 6026729
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2024
• 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