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	03/02/2026
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 a leakage at the clave was reported.Normal saline was involved.There was patient involvement but no patient harm.
Additional Manufacturer Narrative
The device is available for evaluation- it has not been received.The investigation is pending.
Additional Manufacturer Narrative
D9 - date returned to mfr: 4/2/2026 received one (1) used.List #142730490, plum 150 ml burette set.As received the secondary port clave was partially separated from the port on the lid of the burette.Stress marks and a rigid break were observed on the tubing and the clave.The set was leak tested per specifications and leakage was observed.The complaint of a leakage can be confirmed.The probable cause is due to an unintentional bending force during use.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: 24593351
• Report Number: 9615050-2026-00180
• Device Sequence Number: 21215252
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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: NORMAL SALINE, MFR UNK.
• Patient Sex: Unknown