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

Catalog Number	21-7094-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that there was a drug leak from the 0.2 micron filter infusion set.The issue occurred during infusion.There was a therapy delay.There was patient involvement.There was no injury and no medical intervention needed.
Additional Manufacturer Narrative
This complaint was incorrectly filed under this registration number.Please reference mrn 3012307300-2025-07494-00 for details pertinent to this event.

• Brand Name: CADD ADMINISTRATION SETS
• 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 n.; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21971882
• Report Number: 9617604-2025-00214
• Device Sequence Number: 8436687
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: (01)10610586025266(17)290304(10)6053834
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K933390
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: 21-7094-24
• Device Lot Number: 6053834
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown