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	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.D4: only di provided as lot number is unknown.
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 during a procedure while administering lactated ringer's, the tubing shot out of the bulb and solution went all over the patient.There was patient involvement and no adverse event.
Additional Manufacturer Narrative
The customer returned 2 photos for evaluation that confirm the complaint of separation.The customer also received one used device for inspection also.As received the inlet tubing of the bulb pump was observed to be separated.Inspection of the bonding location under uv light showed sufficient solvent.Probable cause of the failure, unknown.Lot history review could not be conducted because not 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: 22055514
• Report Number: 9615050-2025-00238
• Device Sequence Number: 4083969
• Product Code: FPA
• UDI-Device Identifier: 10887787005360
• UDI-Public: 10887787005360
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/18/2025

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: 04/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/18/2025
• 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: LACTATED RINGERS, UNK MFR
• Patient Sex: Unknown