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

Catalog Number	21-7301-24
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: investigation including root cause analysis is in progress.A supplemental mdr will be filled as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that that a 50 ml medicine cassette was returned from the hospital pharmacy's drug manufacturing unit at the office because of a suspected product defect.The cassette had been filled before it was noticed that a dark hair was visible inside the cartridge.There was no patient involvement.
Additional Manufacturer Narrative
D3 - postal code: corrected.H3, h6: updated.The suspect product was returned for evaluation.Visual inspection was performed and was found that there was a hair in between the internal bag and cassette housing, and it was outside the fluid path.The lot history review was performed, and it was confirmed that there were no previous conformities noted.The allegation made by the complainant was confirmed.The probable root cause of the event was due to a gowning error during manufacturing.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 ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; miinneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25183459
• Report Number: 3012307300-2026-05062
• Device Sequence Number: 10385559
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• UDI-Public: (01)10610586027215(17)300526(10)6108560
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2026

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: 21-7301-24
• Device Lot Number: 6108560
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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