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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An event involved a plum 150 ml burette set, clave injection site, 2 clave y-sites, sl.It was stated in the report during medication dosing through the burette, the clave connector suddenly broke.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
The device was not returned for evaluation.Without the return of the 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: 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 NA ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; +1(224)706-2300
• MDR Report Key: 50858810
• Report Number: 9615050-2026-01411
• Device Sequence Number: 9508238
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• Combination Product (Y/N): N
• Initial Reporter State: NA
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 14205121
• 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: 09/02/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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