MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	123390488
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
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 primary plum set, orange polyethylene lined light resistant tubing, clave y-site, secure lock, 103 inch reportedly leaked an unspecified fluid/infusate at the tubing location during a patient's infusion.The patient was not harmed.
Additional Manufacturer Narrative
The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.One used sample and one photo of the set in a bag from the same lot were returned for investigation.As received a small puncture was observed on the tubing.The set was leak tested and a leak was observed from the tubing.The manufacturing process was reviewed and there are no sharp objects or instruments on the manufacturing floor capable of the observed damage as a preventative measure.The complaint of leaking from tubing can be confirmed due to the observed puncture.The probable cause is unknown.

• Brand Name: PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE
• 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: 24264662
• Report Number: 9615050-2026-00056
• Device Sequence Number: 10030664
• Product Code: FPA
• UDI-Device Identifier: 10887787005315
• UDI-Public: (01)10887787005315(17)280601(10)14443210
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 123390488
• Device Lot Number: 14443210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED FLUID/INFUSATE, MFR UNK.
• Patient Sex: Unknown