MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUMSET 3CLV+BKC VALV-SL V PIN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	149510488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested for evaluation- it has not been received.The investigation is pending.
Event or Problem Description
Event occurred regarding a primary plum set where the report stated, ¿propofol infusing and primary rn noted tubing to be leaking medication." the report further stated that "this event occurred during continuous propofol infusion on a ventilated, sedated patient." there was patient involvement, but no one was harmed.
Additional Manufacturer Narrative
One used device was returned for evaluation on 8/29/2025.No damage or anomalies were noted.The set was air pressure leak tested.No leakage was observed.The reported complaint of leakage cannot be replicated or confirmed.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PLUMSET 3CLV+BKC VALV-SL V PIN
• 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: 22883551
• Report Number: 9615050-2025-00401
• Device Sequence Number: 9640893
• Product Code: FPA
• UDI-Device Identifier: 10887787003205
• UDI-Public: 10887787003205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: 149510488
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: PROPOFOL ( MFR UNKNOWN).
• Patient Sex: Unknown