MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOC; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	124350489
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a primary y-type blood set, 200 micron filter, bulb pump, clave y-site, secure lock, 80 inch where it was reported that a set of blood tubing came apart and leaked below the filter while administering blood to a patient.There was patient involvement, potential contamination of iv fluids, and there was a delay in therapy.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
Additional Manufacturer Narrative
A picture was returned showing a red circle outlining the junction between the blood filter and the tube.Additionally received one (1) used list# 124350489 primary y-type blood set attached to a 1000ml iv bag.As received the outgoing tubing of the blood filter was observed to be separated from the blood filter.Inspection of the bonding location under uv light showed insufficient solvent application.The set was found to meet product specification.The complaint of leakage can be confirmed due to the observed separation.The probable cause is due to a solvent application error in during manufacturing in costa rica.A device history review (dhr) lot# review could not be conducted because no lot number(s) was/were identified.

• Brand Name: PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, BULB PUMP, CLAVE Y-SITE, SECURE LOC
• 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: 21151036
• Report Number: 9615050-2025-00030
• Device Sequence Number: 15864446
• Product Code: FPA
• UDI-Device Identifier: 10887787005360
• UDI-Public: 10887787005360
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K143087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 124350489
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/12/2025
• 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
• Patient Sex: Unknown