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

Catalog Number	21-7361-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the device history file was reviewed.There were no discrepancies noted relevant to the indicated failure mode.The devices from the same lot were returned for investigation.The devices were visually inspected.There were no anomalies noted upon visual inspection.There was leaking of the tubing found during testing.The complaint made by the complainant was confirmed.The probable cause was due to an inconsistent solvent coverage at the bond during manufacturing.
Event or Problem Description
It was reported that the admin set was between the pump segment and the hose.There was no reported patient involvement.It was stated that there was no human harm/adverse event.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.No product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
Additional Manufacturer Narrative
D3: mfg.Establishment name updated.D9: device received on 11/19/2025.H3: the device samples and photos were received for evaluation.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.Visual and functional tests were performed, which found during the inspection that leaks were observed in a total of 6 samples, 1 in the union between the pump tube and 5 between the tube adapters.The customer complaint was confirmed.Inconsistent solvent coverage at the tubing-to-adapter bond during manufacturing at the tijuana site, leading to micro-channels and leakage was the probable cause of the issue.

• Brand Name: CADD ADMINISTRATION SETS - FLOW STOP
• 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: 22952110
• Report Number: 3012307300-2025-10290
• Device Sequence Number: 18550892
• Product Code: FPA
• UDI-Device Identifier: 15019517191738
• UDI-Public: (01)15019517191738(17)290817(10)6037805
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2026

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: 21-7361-24
• Device Lot Number: 6037805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 12/22/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 11/14/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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