MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 99" (251 CM) 20 DROP Y-TYPE BLOOD SET W/200 MICRON FILTER, HAND PUMP, 2 CLAVE®,; STOPCOCK, I.V. SET

Catalog Number	B9449
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of air in line could not be confirmed.Without the return of the sample or a photo/video a comprehensive review cannot be performed and a probable cause cannot be determined.
Event or Problem Description
The event involved a 99" (251 cm) 20 drop y-type blood set w/200 micron filter, hand pump, 2 clave®, rotating luer where it was reported that the little dripper gets air in blood set, hard to prime and infuse blood products.The medication being used with this is albumin.There was patient involvement, no patient harm or adverse events.There was delay in therapy.

• Brand Name: 99" (251 CM) 20 DROP Y-TYPE BLOOD SET W/200 MICRON FILTER, HAND PUMP, 2 CLAVE®,
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 23292059
• Report Number: 9617594-2025-01982
• Device Sequence Number: 4783384
• Product Code: FMG
• UDI-Device Identifier: 00887709013902
• UDI-Public: (01)00887709013902
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K964435
• 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
• Report Date (Section B): 10/14/2025

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: B9449
• 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: 09/17/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ALBUMIN, MFR UNK
• Patient Sex: Unknown