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 Codes	Fluid/Blood Leak (1250); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for investigation.Without the return of the device a probable cause is unable to be determined.
Event or Problem Description
The event occurred on an unspecified date and involved a 6" bifuse ext set w/2 check valves, rotating luer where the customer reported that they have had at least 4 devices break at the luer adapter male end and that at least 2 instances were the patient did not receive their iv medications for at least 30 minutes causing clinical deterioration.The nurses did not over-tighten the device to the patient¿s iv catheter.The patient¿s norepinephrine infusion and vasopressin infusions were not infusing causing the patient¿s blood pressure to drop to 65/42, the infusions were restarted and the patient improved over the course of the next 30 minutes.The device was found broken (not when luer locking to iv catheter).There was patient involvement, but no harm was reported as a consequence of this event.
Additional Manufacturer Narrative
The complaint on the b1003 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.Lot history review was performed and no non conformities were found that would have led to the reported complaint.

• 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: 19271669
• Report Number: 9617594-2024-00557
• Device Sequence Number: 20609871
• 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,Followup
• Report Date (Section B): 05/10/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/09/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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: NOREPINEPHRINE AND VASOPRESSIN, MFR UNK.
• Patient Sex: Unknown