MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 147" (373 CM) BIFUSE 10 DROP BLOOD SET W/170 MICRON FILTER, HAND PUMP, 2 CLAVE®; STOPCOCK, I.V. SET

Model Number	B5216
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation, however has not been received.
Event or Problem Description
The event involved a 147" (373 cm) bifuse 10 drop blood set w/170 micron filter, hand pump, 2 clave® w/remv 3 gang 1o2® manifold (blue, yellow, red), check valve rotating luer, 1 ext, where it was reported that air was present in line closest to the patient's central port.The patient was being transported from the operating room (or) to the intensive care unit (icu), was intubated and sedated, and receiving a blood infusion.The attending doctor noted the air in line and did not know how much air entered the patient's system.Upon closer look, it was noted that the blue port was depressed and perhaps allowed the air to enter.The issue was resolved by replacing the blood tubing.There was patient involvement, however no report of patient harm.
Additional Manufacturer Narrative
The complaint of a stick down can be confirmed on the returned one used partial list #b5216, 147" (373 cm) bifuse 10 drop blood set w/170 micron filter, hand pump, 2 clave® w/remv 3 gang 1o2® manifold (blue, yellow, red), check valve rotating luer, 1 ext; lot #6037886.As received the silicone seal of the y-clave on the partial set was stuck down.The y-clave was disassembled to evaluate the seal and spike.The seal was torn on the top surface of the seal.The spike was crushed and twisted.No damages or anomalies noted on the returned new b5216.The probable cause of the damaged seal and internal spike is due to access with an incompatible mating device during use.The dfu states: "connectors are compatible with iso male luers having an internal diameter between 0.062¿ and 0.110¿." the device history review (dhr) for lot 6037886 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: 147" (373 CM) BIFUSE 10 DROP BLOOD SET W/170 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15805825
• Report Number: 9617594-2022-00303
• Device Sequence Number: 14802897
• Product Code: FMG
• UDI-Device Identifier: 00887709067615
• UDI-Public: (01)00887709067615(17)270601(10)6037886
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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 Model Number: B5216
• Device Catalogue Number: B5216
• Device Lot Number: 6037886
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: BLOOD COMPONENT.; CENTRAL LINE PORT, UNK MFR.
• Patient Sex: Unknown