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

Catalog Number	21-7115-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a leak was found at the proximal y site of the tubing.Per reporter, the cap was never handled and only part of the medication had been administered.There was patient involvement.No patient harm/adverse event was reported.
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
H3: one used product and video were returned for evaluation.Visual inspection identified some crazing at the y-site luer bond that was observed to be leaking in the returned video.Functional testing was performed and a leak was observed between the asv luer and y-site.The set was leak tested from the end luer.Upon further inspection it was observed that the connection showed movement.During inspection the female to male luer bond broke with the male luer remaining lodged in the female luer.In attempts to better visualize any potential source of leak, the female luer with the male luer lodged inside was plugged using a pin gage.The section of the set was then connected to an air source and put underwater to visualize any leakage and no leakage was observed.The customer complaint of leakage was confirmed; however, the root cause of the issue was unknown.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL 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: 23951424
• Report Number: 3012307300-2026-00032
• Device Sequence Number: 18828927
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: (01)10610586034503(17)200929(10)6054063
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 21-7115-24
• Device Lot Number: 6054063
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MORPHINE
• Patient Sex: Unknown