MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	14220-01
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Event or Problem Description
The event involved a primary plum y-type blood set, 200 micron filter, clave secondary port, clave y-site, non-vented, secure lock, 110 inch.It was reported that the normal saline leaked from the clave of the cassette after blood transfusion.There was no bleedback reported.There was patient involvement reported, and no patient harm/adverse event reported.There was no delay in critical therapy.
Additional Manufacturer Narrative
Received one device for inspection.As received, the b port was stuck down no other damage or anomalies observed as returned.No mating device was returned.The set was tested per product specifications.The clave was disassembled, and the silicone seal was found to be cored and torn typical of damage from an incompatible mating device.The reported complaint of blue clave leakage is confirmed.The damage observed is typical of access with an incompatible mating device.No mating device was returned.The directions for use states: the clave connector is compatible with luers with an internal diameter (id) between 1.55 mm and 2.8 mm.Lot history review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PRIMARY PLUM Y-TYPE BLOOD SET, 200 MICRON FILTER, CLAVE SECONDARY PORT, CLAVE Y-
• 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: 22322624
• Report Number: 9615050-2025-00313
• Device Sequence Number: 18347609
• Product Code: FPA
• UDI-Device Identifier: 10887787002475
• UDI-Public: 10887787002475
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 14220-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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