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

Catalog Number	21-7359-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon inspection of the tubing and setup, there was a clear break in the seal at the junction of the tubing on the walkmed bag and the leur lock.The picture below was not great, but it gives the idea of where the break was.When they pushed the fluid through the tubing, there was an obvious loss of fluid, they felt confident that this occurred after it was made and delivered to oncology.No patient harm or no patient injury.The event occurred immediately on use.The operator of the device was a health professional.
Additional Manufacturer Narrative
A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
H6: codes were updated.No device was received for investigation.Therefore, the reported complaint is unable to be confirmed.If the device is received, the investigation will be re-opened for further evaluations.Based on the review of the service history and information provided from the customer we are unable to determine a probable cause as the device was not returned for evaluation.No event history log provided.

• Brand Name: CADD ADMINISTRATION SET
• 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 ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24081204
• Report Number: 3012307300-2026-00368
• Device Sequence Number: 9756017
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: (01)10610586027406(17)300407(10)6108326
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: 21-7359-24
• Device Lot Number: 6108326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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