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

Catalog Number	21-7324-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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 reportable information becomes available.
Event or Problem Description
It was reported that on an epidural catheter in l1-l2, they found a leak at the level of the tubing near the thread connection with the filter.Date of installation was on (b)(6) 2025.Immediate actions were stopping the syringe pump and removing the epidural catheter 24 hours before the prescribed date.Immediate apparent consequences for the patient were discontinuation of the administration of analgesics with a risk of uncontrolled analgesia in a 13-month-old child, potential infectious risk due to the rupture of the closed system and risk of gas embolism with probable air entry into the system.The incident was reported to ansm.There was patient involvement, but no patient harm reported.
Additional Manufacturer Narrative
D4.Primary udi number: correction.H3 and h6.Codes: updated.One (1) used administration set, and two (2) customer images were returned showing the sample and the suspected leak site.As received, there were no damages or anomalies observed.To replicate clinical use, the administration set was spiked onto the returned medication bag backfilled with 100ml of water.The administration set was then installed onto a cadd-solis 2110 pump and 6.2ml of priming was performed.No leaks were observed.In order to detect leakage, the sample was tested using a hydrostatic pressure pump as per the manufacturing procedure.A leak was observed from the asv valve short tubing and the rest of the tubing.A bond pull test was performed on the asv valve-tubing connection and the tubing was observed to break before the tubing was pulled out from the bond.The complaint of leakage was confirmed, and the probable cause is due to a solvent application error during manufacturing.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.
Additional Manufacturer Narrative
H2: supplemental generated to capture the updated lot history review.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; avenida calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 24060605
• Report Number: 3012307300-2026-00337
• Device Sequence Number: 21198694
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: (01)10610586029653(17)300618(10)6125863
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2026

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: 21-7324-24
• Device Lot Number: 6125863
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Supplement Date Received by Manufacturer: 02/24/2026; 03/24/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2025
• 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