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	04/28/2025
Type of Reportable Event	Malfunction
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 where it was reported blood leaked during blood transfusion.There was patient involvement and unknown harm reported.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not yet been received.D4: only di provided as lot number is unknown.
Additional Manufacturer Narrative
Additional information can be found in b5, d4 and h4.Corrected information can be found in the concomitant products section, and throughout section e.Additional contact: (b)(6).
Event or Problem Description
The customer provided additional information 06-may-2025 informing that the lot number is 13850990 and that there was no patient harm.
Additional Manufacturer Narrative
Investigation summary one (1) photo provided for evaluation.The photo provided was unable to confirm the complaint of blood leaking from the tubing set.The dhr for lot number 13850990 was reviewed, no relevant nonconformities observed that would have contributed to this complaint.The probable cause could not established without the product returned.

• 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: 22096747
• Report Number: 9615050-2025-00264
• Device Sequence Number: 8060371
• Product Code: FPA
• UDI-Device Identifier: 10887787002475
• UDI-Public: (01)10887787002475(17)270201(10)13850990
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 13850990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 06/11/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/03/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/26/2024
• 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 BLOOD INFUSATE/PRODUCT/UNIT, MFR UNK
• Patient Sex: Unknown