MAUDE Adverse Event Report: ICU Medical Healthcare Manufacturing S.A. de C.V. CADD Medication Cassettes Ambulatory Pump Disposals-; Set, Administration, Intravascular

Catalog Number	21-7609-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the luer-lock adapter leaked despite being tightly secured.The issue affected patient care and was resolved by replacing the product.There was a patient involvement and there were no additional adverse consequences.
Additional Manufacturer Narrative
B3 - date of event is unknown.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.

• Brand Name: CADD Medication Cassettes Ambulatory Pump Disposals-
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): ICU Medical Healthcare Manufacturing S.A. de C.V.; avenida calidad no.4, parque; industrial internacional; tijuana NA 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; +1(224)706-2300
• MDR Report Key: 50114339
• Report Number: 3012307300-2026-07827
• Device Sequence Number: 5252687
• Product Code: LHI
• UDI-Device Identifier: 10610586044014
• UDI-Public: (01)10610586044014(17)270407(10)6108514
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: AU
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2026

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: Other
• Device Catalogue Number: 21-7609-24
• Device Lot Number: 6108514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 08/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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
• Patient Sex: Unknown