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

Catalog Number	21-7302-24
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cassette, inspected before use (empty), once filled with solvent and chemotherapy, there was a blue-black particle at the level of the bag.A new cassette was then prepared after verifying the absence of any particle.A second cassette, belonging to the same lot, also presented a visible particle at the level of the bag.It was not possible to determine whether these particles were inside the bag or located outside of it, between the flexible bag and the rigid structure of the cassette.The two cassettes were not brought into contact with chemotherapy due to the prior detection of the particle.Issue occurred at the time of preparing chemotherapy in our preparation unit.Cassette discarded and new cassette used for preparation.There was no patient involvement.
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 reportable information becomes available.
Additional Manufacturer Narrative
Two used devices were returned for investigation.Device history review was performed, and no nonconformities were identified that may have contributed to the reported complaint.The device was visually inspected, and no anomalies were noted.Upon closer inspection one particulate matter was observed from each cassette.Both particulate matters were found outside the cassette bag and within the hard casing.The cause of the reported issue was unknown.It is not anticipated that the reported malfunction would result in interruption of therapy or serious injury.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• 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
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24875389
• Report Number: 3012307300-2026-03709
• Device Sequence Number: 21107345
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: (01)10610586027239(17)300812(10)6140883
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 21-7302-24
• Device Lot Number: 6140883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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