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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a plum 150 ml burette set, clave injection site, 2 clave y-sites, sl, 114in where it was reported that the clave additive port disconnected.No drug was involved in the event.The event occurred during infusion.There was patient involvement, but no harm reported.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.Additional reporter: (b)(6).
Additional Manufacturer Narrative
Additional information: d9 - date returned to mfr - 16feb2026.Investigation summary received one (1) used 142730490 plum 150 ml burette set for evaluation.As received the secondary port clave was separated and broken off from the port on the lid of the burette.Stress marks and a rigid break were observed on the clave and on the port.The lot history was reviewed; no nonconformities were identified that may have contributed to the reported complaint.The complaint of broken clave can be confirmed.The probable cause is due to an unintentional bending force during use.

• 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: 24073986
• Report Number: 9615050-2026-00014
• Device Sequence Number: 10226958
• Product Code: FPA
• UDI-Device Identifier: 10887787008804
• UDI-Public: (01)10887787008804(17)280501(10)14336966
• 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,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 14336966
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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