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	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available for evaluation, however, has not yet been received.E1 initial reporter phone number: (b)(6).
Event or Problem Description
The event occurred on an unspecified date and 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 the spike on the icu medical tubing is clotting off.When this happens, it causes a vacuum in the tubing that doesn¿t allow the blood products to move forward to the patient; the bulb for squeezing collapses.It was reported the event hindered and slowed the transfusion process, and a wastage of blood products due to having to switch to fresh blood y typed tubing.The event occurred while actively trying to transfuse packed red blood cells to patients in the operating room.There was patient involvement and no patient harm.
Additional Manufacturer Narrative
A series of photos were shared by the customer, where the item and lot information are shown, but the most representative photo showed blood clotting the inside of the dry chamber, which is no flowing through the set, no additional damage or anomalies are observed.Complaint of blood cannot flow properly can be confirmed based on the photos shared by the customer.However, since no product sample was received for investigation a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.

• 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: 20135280
• Report Number: 9617594-2024-01248
• Device Sequence Number: 7278150
• Product Code: FMG
• UDI-Device Identifier: 00887709013902
• UDI-Public: (01)00887709013902(17)290301(10)13917946
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 11/11/2024

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: 13917946
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 09/04/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: PACKED RED BLOOD CELLS
• Patient Sex: Unknown