MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD EXTENSION SET; ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS

Catalog Number	21-7605-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).H3: investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Event or Problem Description
It was reported that there was a leak on the hose running between the filter and the cassette.There was patient involvement, but no injury.
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 tubing, which was determined to have been insufficiently inserted into the valve.The investigation attributed the issue to an error during the manufacturing process.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.Complaint information will continue to be monitored.

• Brand Name: CADD EXTENSION SET
• Common Device Name: ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4; parque industrial intl; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21627206
• Report Number: 3012307300-2025-02998
• Device Sequence Number: 20920412
• Product Code: PWH
• UDI-Device Identifier: 10610586044113
• UDI-Public: (01)10610586044113
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K162219
• 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: Non-Healthcare Professional
• 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 Catalogue Number: 21-7605-24
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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