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

Model Number	21-7309-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cassette containing fentanyl 2 mcg/ml-ropivacaine was found to be leaking during the receiving process.Per reporter the bag was found to be ¿wet and dripping on the pharmacist¿ when the bag containing the cassette was being placed into the storage system for controlled substances.No adverse effects were reported as a result of the alleged contact.The reporter stated that the clamp on the cassette on the pigtail tubing had not been closed as required, although the red luer-lock cap had been properly secured.It was reported that no physical damage was observed on the cassette or its tubing; however, liquid was observed inside the yellow casing.Per reporter manual pressure had been applied to the bladder and a leak was observed in a corner of the bladder along the seam, opposite the blue flow stop clip.
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
A device history record review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, no visual and functional tests were performed, the reported complaint could not be confirmed, and the root cause could not be determined.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: CADD CASSETTE RESERVOIR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL MANUFACTURING S.A. DE C.V.; avenida calidad no.4; parque industrial int; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22978576
• Report Number: 3012307300-2025-10332
• Device Sequence Number: 13075661
• Product Code: FPA
• UDI-Device Identifier: 10610586032387
• UDI-Public: (01)10610586032387(17)291026(10)6068936
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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: 21-7309-24
• Device Catalogue Number: 21-7309-24
• Device Lot Number: 6068936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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