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

Model Number	7301
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
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.
Event or Problem Description
It was reported that there were particles in the 50 ml grey cadd cassettes.These cassettes are used by integradose for delivery of the controlled substance fentanyl citrate.Staff has identified these particles as ¿2 crescent-shaped slivers, mostly plastic in nature, and one very small roundish and opaque particle.¿ these particles are similar to those they have been seeing at integradose.The event occurred during visual inspection so there was no patient involvement.
Additional Manufacturer Narrative
D8 - updated.H3 and h6 ¿ updated.No sample was received.However, two photographs were received.These images show two crescent-shaped splinters, mostly made of plastic, along with a very small, rounded, opaque particle.The customer complaint was confirmed through provided photo.However, it cannot be determined whether the particles are located outside or inside the cassette.The device history file was reviewed.There were no non-conformities were identified that may have contributed to the reported complaint.If the product is returned, this complaint will be reopened for further investigation.

• 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; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24756879
• Report Number: 3012307300-2026-03172
• Device Sequence Number: 21176376
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• UDI-Public: (01)10610586027215(17)301003(10)6140873
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2026

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 Model Number: 7301
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 6140873
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2025
• 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