MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4-WAY HIGH FLOW STOPCOCK W/ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number	B4018
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.
Event or Problem Description
The event involved a 4-way high flow stopcock w/rotating luer where it was reported that the lines unscrew from them very easily and with pressure causes them to disconnect.The product was used on a patient at the time of the incident.There was no delay in the critical therapy when the problem was noted.Additionally, staff were almost finished with the procedures when the item failed.Staff noted that when they initially connect to the stopcock the lines do not disengage.But once they removed the line and attached it again, it would start to disengage (unscrew) on its own.During patient use, it did start to leak when applying pressure from a syringe.But if staff noticed it not working, they switched to a new stopcock.There was no serious deterioration in the state of health of a patient, user, or other, and no death of a patient, user, or other person, and no potential for death or serious deterioration in health of a patient, user, or other person there was patient involvement, no adverse event, and no delay in therapy.
Additional Manufacturer Narrative
Forty-nine (49) new.List #b4018 were returned for evaluation.As received no anomalies or damages were observed on the sample.No mating device was returned for evaluation.The female and male luer met iso design specification of the sample were found within specification and based on the binomial stages sampling to represent the lot population 35 samples were taken and passed the spin collar retention test as well.Complaint of disconnection / loose connection cannot be confirmed or replicated.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 9/6/2024.

• Brand Name: 4-WAY HIGH FLOW STOPCOCK W/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: 20078853
• Report Number: 9617594-2024-01218
• Device Sequence Number: 12724581
• Product Code: FMG
• UDI-Device Identifier: 00887709008694
• UDI-Public: (01)00887709008694(17)290401(10)13992957
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: B4018
• Device Lot Number: 13992957
• 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: 08/01/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown