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

Catalog Number	21-7300-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that the product has a sliced tubing.It was also added that white clamp on the tubing leading to the red cap was damaging the line by cutting through plastic.There was no patient involvement or harm.
Additional Manufacturer Narrative
A device history record (dhr) 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.In the complaint, the product has a sliced tubing.It was also added that white clamp on the tubing leading to the red cap was damaging the line by cutting through plastic.The event was determined not to meet the manufacturer¿s reportability criteria because the device did not cause or contribute to a death or serious injury, nor did the malfunction present a risk that would be likely to cause or contribute to a death or serious injury if it were to recur.

• 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 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24944540
• Report Number: 3012307300-2026-04049
• Device Sequence Number: 14804151
• Product Code: FPA
• UDI-Device Identifier: 10610586027192
• UDI-Public: (01)10610586027192(17)300719(10)6132925
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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: 21-7300-24
• Device Lot Number: 6132925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 04/21/2026
• Supplement Report FDA Received Date: 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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