MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6" BIFUSE EXT SET W/2 CHECK VALVES, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B1003
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	High Blood Pressure/ Hypertension (1908)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The folllowing items were provided by the customer for complaint investigation: one used list #b1003, 6" bifuse ext set w/2 check valves, rotating luer; lot #13771580; two used manufacturer unknown, microclaves; lot #unknown.The secure lock collar at the male luer of the 6" bifuse ext set w/2 check valves, rotating luer was observed to be cracked and broken apart.The male luer was fully connected to a female luer and the set was leak tested per product specifications.There was no leakage with the male luer to female luer connection remaining engaged.The reported complaint of a broken secure lock collar and subsequent leakage due to a disconnection can be confirmed.The probable cause is due to environmental stress cracking during use.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The complaint/event occurred on an unspecified date and involved a 6" bifuse ext set w/2 check valves, rotating luer that reportedly broke (in situ) while it was connected to a patient¿s iv access during a propofol infusion.This resulted in a leak of intravenous propofol onto the bed.There was no human harm reported associated with the event.However, the event was reported to be a 'near miss' because the patient became very agitated, their blood pressure went up to a systolic of 200, and the patient almost self-extubated.

• Brand Name: 6" BIFUSE EXT SET W/2 CHECK VALVES, ROTATING LUER
• 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: 19263068
• Report Number: 9617594-2024-00550
• Device Sequence Number: 16815794
• Product Code: FMG
• UDI-Device Identifier: 00887709000018
• UDI-Public: (01)00887709000018(17)280901(10)13771580
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 05/07/2024

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: B1003
• Device Lot Number: 13771580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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: PROPOFOL, MFR UNK.; UNSPEC. INTRAVENOUS (IV) ACCESS DEVICE, MFR UNK.
• Patient Sex: Unknown