MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, CONVERTIBLE PIN AND NON-VENTED PIN,; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	142059290
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.A lot number was not provided.Without a lot number a device history lot review cannot be performed.E1: (b)(6).D4: (b)(4).
Event or Problem Description
The event involved a primary y-type blood set, 200 micron filter, secure lock, 80 inch.The problem was: the drip chamber, which contains the filter for the transfusion tubing, burst when the nurse was handling it near the end of the blood transfusion, and the blood "exploded" on the nurse.The nurse was using the tube for a blood transfusion.She was near the end and wanted to get all the blood out of the bag in the room, so she gave it a little pressure, and it burst.Blood spilled everywhere.No defects were noticed before using the product.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
One (1) photo provided for evaluation; three (3) photos provided; one (1) photo confirms the complaint of drip chamber burst.No 142059290 samples were provided for evaluation.The reported complaint can be confirmed from the photos provided.The probable cause could not be determined without the return of the failed product.

• Brand Name: PRIMARY Y-TYPE BLOOD SET, 200 MICRON FILTER, CONVERTIBLE PIN AND NON-VENTED PIN,
• 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: 22055056
• Report Number: 9615050-2025-00236
• Device Sequence Number: 11824860
• Product Code: FPA
• UDI-Device Identifier: 10887787007142
• UDI-Public: 10887787007142
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 142059290
• Device Lot Number: UNKNOWN
• 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: 04/22/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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