MAUDE Adverse Event Report: ICU MEDICAL, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7092-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).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.
Event or Problem Description
It was reported that while the patient infusion was in progress, the tubing broke at the y-junction.The tubing was promptly replaced with a new one.There was no patient injury.
Additional Manufacturer Narrative
D9: 22-oct-2025.H3: one used product from lot number 6037845 was received for evaluation.Visual inspection of the device observed it to be broken and separated at the y-connection site.Two units of list #21-7092-24 were received and the male luer check valve bond was observed to be broken on both sets.The deformation of the breaks showed beach mark and smooth sections.Functional testing was performed, and no leakage was observed on either set.The complaint of broken y junction site can be confirmed.The probable cause of the damage is due to excessive bending/twisting forces applied during use.The lot history was reviewed; no relevant nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; ave calidad no. 4, parque; industrial internacional; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22798414
• Report Number: 3012307300-2025-09676
• Device Sequence Number: 18221327
• Product Code: FPA
• UDI-Device Identifier: 10610586024177
• UDI-Public: (01)10610586024177(17)290826(10)6037845
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 21-7092-24
• Device Lot Number: 6037845
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown