MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. CADD CASSETTE RESERVOIRS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7002-24
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3/h6: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two used devices from the same lot were returned for investigation.The devices were visually inspected.There was a particulate matter (pm) found in fluid path (ifp).Both samples fail product specifications due to presence of: - loose pm found ifp and the complaint of debris in the cassette can be confirmed due to the loose particulates found within the cassette.The probable cause is unknown.
Event or Problem Description
The customer reported that they had 100ml cassette each day rejected due to particulate matter.Both contains 5 fu.Per reporter, there was no patient involvement.Evaluation of the returned device was confirmed the loose particulates found within the cassette.

• Brand Name: CADD CASSETTE RESERVOIRS - NON FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24304517
• Report Number: 3012307300-2026-01108
• Device Sequence Number: 20119469
• Product Code: FPA
• UDI-Device Identifier: 10610586022128
• UDI-Public: (01)10610586022128(17)291125(10)6070584
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K843772
• 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
• Report Date (Section B): 02/10/2026

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: 21-7002-24
• Device Lot Number: 6070584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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