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	Fluid/Blood Leak (1250); No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 4-way high flow stopcock w/rotating luer generated a leak during patient use.As per report, the stop cock is intermittently blocked and leaking at different side at start of use; during induction phase when it is at a critical time.The device is available for investigation.There was patient involvement and there was no adverse event reported.
Additional Manufacturer Narrative
Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.
Additional Manufacturer Narrative
One (1) used sample #b4018 was returned for evaluation.As received no physical damage on the stopcock's lines or anomalies were observed.No mating device was returned.The sample was primed and leak-tested, and no anomalies were confirmed.The male luer of the device was measured and met iso product design.Complaints of leaks cannot be confirmed or replicated.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.D9 - date returned to mfg: 7/8/2024.

• 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: 19641168
• Report Number: 9617594-2024-00856
• Device Sequence Number: 15605820
• Product Code: FMG
• UDI-Device Identifier: 00887709008694
• UDI-Public: (01)00887709008694(17)281001(10)13797203
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2024

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: 13797203
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/26/2024
• Initial Report FDA Received Date: 06/30/2024
• Supplement Report FDA Received Date: 08/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2023
• 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
• Patient Sex: Unknown