MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MC33371
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be received for evaluation, however, it has not yet been received.
Event or Problem Description
The event involved a 4.5" smallbore bifuse ext set w/2 microclave® clear, 2 clamps, luer lock where the customer reported that at around 2000 the ecmo (extracorporeal membrane oxygenation) the registered nurse noticed blood dripping down the patient's bed.Upon further inspection it was found that the smallbore bifuse connected to the right internal jugular vein central venous access (ij cvl) had broken and blood was dripping from the ij into the bed.The broken bifuse was immediately clamped and when new supplies were gathered it was removed from the patient.There was a patient involvement and no harm or adverse event reported as a consequence of the event.
Additional Manufacturer Narrative
The complaint on the mc33371 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history record was reviewed and no non-conformities were found that would have led to the reported complaint.
Event or Problem Description
Additional information was received as follows: a medsun medwatch uf/importer report #(b)(4) received on 30-aug-2024 providing additional event information obtained from ufmw: the patient involved is a 2-year-old female.The type of record was product problem.This was not a single-use device that was re-processed and reused on a patient.This is an initial type of report, and the event occurred in the hospital.

• Brand Name: 4.5" SMALLBORE BIFUSE EXT SET W/2 MICROCLAVE® CLEAR, 2 CLAMPS, LUER LOCK
• 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: 19933589
• Report Number: 9617594-2024-01088
• Device Sequence Number: 11474808
• Product Code: FMG
• UDI-Device Identifier: 00887709038172
• UDI-Public: (01)00887709038172(17)290301(10)13953074
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: MC33371
• Device Lot Number: 13953074
• 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: 07/10/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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: ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION), MFR UN.; RT INT JUGUL. VEIN CENTRVENOUSACCDEVICE, MFR UNK.
• Patient Age: 24 MO
• Patient Sex: Female