MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, S; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	15247-28
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable root cause is unable to be determined.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a primary plum set, clave secondary port, clave y-site, distal microbore tubing, secure lock, 104 inch and it was reported that the rubber stopper seal inside the blue clave attached to the primary plum tubing set gets stuck and does not allow for back priming or proper infusion of medication from secondary cassette.The problem usually occurred during infusion specifically when back priming primary fluid into secondary tubing.The medication that was involved are normal saline 0.9% and dextrose 5% there was delay in therapy each time this happened it causes around 5 ¿ 10 minutes of patient delays while the nurse gets an entirely new set of primary and secondary tubing.There was patient involvement with no patient harm.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, DISTAL MICROBORE TUBING, S
• 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: 24893008
• Report Number: 9615050-2026-00233
• Device Sequence Number: 10019458
• Product Code: FPA
• UDI-Device Identifier: 00887709102057
• UDI-Public: (01)00887709102057(17)280101(10)14218807
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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: 15247-28
• Device Lot Number: 14218807
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2025
• 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: DEXTROSE 5%, UNK MFR; NORMAL SALINE 0.9%, UNK MFR; SECONDARY CASSETTE, ICU MEDICAL
• Patient Sex: Unknown