MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD DISPOSABLE CASSETTES; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7345-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.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 reportable information becomes available.
Event or Problem Description
It was reported that there was a leaking at port.There was unknown patient involvement.
Additional Manufacturer Narrative
D3 - postal code: corrected.H3/h6: one sample was returned in unused condition for analysis.Functional and visual tests were performed, while injection liquid was given to the sample, no leak was detected.The reported issue of leaking was not duplicated.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The cause of the reported issue was not determined as no issue was identified through testing.

• Brand Name: CADD DISPOSABLE CASSETTES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24093328
• Report Number: 3012307300-2026-00371
• Device Sequence Number: 18694453
• Product Code: FPA
• UDI-Device Identifier: 15019517191714
• UDI-Public: (01)15019517191714(17)3000225(10)6093190
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K031361
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 21-7345-24
• Device Lot Number: 6093190
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown