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

Model Number	7309
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a small hair was found inside the end of the filling port.The issue was discovered during the filling of the cassette in the cleanroom.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 information becomes available.
Additional Manufacturer Narrative
Received one device.Visual inspection found hair contamination observed inside of the luer.Two pictures were returned.Image one showed the 250ml cassette, image two showed a close up of the female luer where what appears to be a hair strand.The complaint of hair inside the end of the filling port can be confirmed.The lot history was reviewed, no relevant nonconformities were identified that may have contributed to the reported complaint.

• 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 n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 23513056
• Report Number: 3012307300-2025-12262
• Device Sequence Number: 9666732
• Product Code: FPA
• UDI-Device Identifier: 10610586032387
• UDI-Public: (01)10610586032387(17)280103(10)4349101
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (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): 12/10/2025

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 Model Number: 7309
• Device Catalogue Number: 21-7309-24
• Device Lot Number: 4349101
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/31/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2023
• 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