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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for return; however, it has not yet been received.
Event or Problem Description
A plum 150 ml burette set, clave injection site, 2 clave y-sites, sl, 114in that reportedly dripped an unspecified chemotherapy downward, even after closing the air vent during patient administration (after priming).The customer stated that the drug leaked out through the clave from the full infusion bag.There was no patient harm and no unprotected chemotherapy exposure.

• 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 IL 60045 ; CS 60045
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest 60045 ; 2247062300
• MDR Report Key: 25059729
• Report Number: 9615050-2026-00266
• Device Sequence Number: 10131920
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)280601(10)14444869
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: 14444869
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: IV BAG FILLED W/ UNSPECIFIED CHEMOTHERAPY, MFR UNK.
• Patient Sex: Unknown