MAUDE Adverse Event Report: ICU MEDICAL 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	03/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a small drop of chemotherapy solution leaked from the backside of the filter.A few orange/red dots noted to sleeve of his central line.Upon further inspection, the nurse noted that there was a tiny amount of fluid leaking from the back side of circular filter.Leak did not reach patient as he had a transparent dressing between the filter and his skin.There was patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
D3 - zip code: must be blank and d3 - postal code: updated.D4 - lot #: corrected.D9 - date returned to mfr: 30-apr-2026.H3 and h6 codes: updated.Three products were returned for evaluation.The lot history was reviewed, and no nonconformities were identified that could have contributed to the reported complaint.Visual inspection and functional testing were performed.The complaint of leakage was confirmed.The probable cause was determined to be the filter's loss of hydrophobic properties.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL 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 ; +1(224)706-2300
• MDR Report Key: 24940172
• Report Number: 3012307300-2026-04027
• Device Sequence Number: 5651023
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: (01)10610586027536(17)301204(10)6164868
• Combination Product (Y/N): N
• 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: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2026

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: 6164868
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY SOLUTION, UNK MFR
• Patient Age: 71 YR
• Patient Sex: Male