MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142730490
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint/event involved a plum 150 ml burette set, clave injection site, 2 clave y-sites, sl, 114in where the customer reported a leak during patient use.The customer stated that shortly after initiating the infusion, the nurse returned to find the 150ml burette inexplicably filled with an unspecified fluid/medication.It was observed that fluid was leaking from the lower edge of the blue clave on the secondary port.When the customer attempted to inspect the device, the blue clave detached.There was no unprotected drug exposure to either patient or healthcare professional(s).There was patient involvement, but harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The device is reported to be available ¿ it states that the sample picture is not available so i would update the h11 to state: the device is reported to be available for evaluation; however, it has not yet been received.
Additional Manufacturer Narrative
No product samples, pictures, or videos were received for investigation.The complaint cannot be replicated or confirmed.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN
• 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: 24012244
• Report Number: 9615050-2026-00007
• Device Sequence Number: 9406213
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)280501(10)14336965
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 142730490
• Device Lot Number: 14336965
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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