MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. Y-TYPE MINIBORE PCA SET, INTEGRAL PAV, INJECTOR ASSEMBLY, 0.2 MICRON FILTER, SEC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142790489
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The event occurred on an unspecified and involved a y-type minibore pca set, integral pav, injector assembly, 0.2 micron filter, secure lock, 86 inch where the customer reported that the pca line hooked up to the patient was leaking hydromorphone leaking.The customer inspected the tubing and found it to have a split in it near the vial and pca machine.The pca line line was changed out but hydromorphone vial reused.Immediate action was done when they replaced the tubing.There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is not available for evaluation, however, a device history review will be performed.
Additional Manufacturer Narrative
The complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: Y-TYPE MINIBORE PCA SET, INTEGRAL PAV, INJECTOR ASSEMBLY, 0.2 MICRON FILTER, SEC
• 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: 21735011
• Report Number: 9615050-2025-00141
• Device Sequence Number: 21023592
• Product Code: FPA
• UDI-Device Identifier: 10887787005506
• UDI-Public: (01)10887787005506(17)260801(10)13670622
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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 Expiration Date: 08/01/2026
• Device Catalogue Number: 142790489
• Device Lot Number: 13670622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2026
• 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: HYDROMORPHONE, MFR UNK
• Patient Sex: Unknown