MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NDEHP PCA EXT SET 10IN WVALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142780438
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.The investigation is pending completion.
Event or Problem Description
Event occurred regarding ndehp pca ext set 10in wvalve where the reporter stated that 2 parts of the iv snapped during infusion and the patient's drug began to leak.There was patient involvement, no adverse event and no delay in therapy as a result of this event.
Additional Manufacturer Narrative
Investigation summary: received one (1) new.List #142780438, ndehp pca ext set 10in wvalve for inspection.As received, no damage or anomalies were observed.The set was leak tested, and no leaks were observed.The complaint of tubing breaking and leaking cannot be replicated or confirmed without the return of the used set.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: NDEHP PCA EXT SET 10IN WVALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22723499
• Report Number: 9615050-2025-00373
• Device Sequence Number: 18384488
• Product Code: FPA
• UDI-Device Identifier: 10887787005483
• UDI-Public: 10887787005483
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2025

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: 142780438
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: MEDICATION, MFR UNKNOWN.
• Patient Sex: Unknown