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

Catalog Number	21-7394-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
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.Investigation is still in progress.
Event or Problem Description
The reporter stated that they had leaking at the air-eliminating.The patient on 24h infusion of epoch, noted wetness at the filter.Picture provided.There was patient involvement.
Additional Manufacturer Narrative
H3: the device was received for evaluation.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.Visual and functional tests were performed, which confirmed the complaint of leakage at the air vent of the inline air filter.The probable cause was due to the filter losing its hydrophobic properties.There was no further action taken.

• 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 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minnepolis, MN 55442 ; 2247062300
• MDR Report Key: 22708312
• Report Number: 3012307300-2025-09268
• Device Sequence Number: 13001431
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: (01)10610586027536(17)270401(10)4264382
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 21-7394-24
• Device Lot Number: 4264382
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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