MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX; STOPCOCK, I.V. SET

Model Number	MX4341L
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the device's 3-way stop was leaking while giving the injection.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation (02/09/2022): no product was returned.This complaint is related to a series of other complaints included (b)(4) which included a photo showing the location of the leak.The reported leaking is coming from the b port where the protector is located that is used for shipping and protection purposes.It appears as though the customer is attempting to use this protector as a dead end to close off this port.These protectors are not intended for use and do not seal the port.There are plugs that are made by icu dublin that can be used to close this port if need be.Potential useable plug could be mx491.No ncmrs were recorded for the affected lot.The cause of the reported problem was traced to the user manipulation of the device.
Event or Problem Description
It was reported the device's 3-way stop was leaking while giving the injection.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation (02/09/2022): no product was returned.This complaint is related to a series of other complaints included (b)(4) which included a photo showing the location of the leak.The reported leaking is coming from the b port where the protector is located that is used for shipping and protection purposes.It appears as though the customer is attempting to use this protector as a dead end to close off this port.These protectors are not intended for use and do not seal the port.There are plugs that are made by icu dublin that can be used to close this port if need be.Potential useable plug could be mx491.No ncmrs were recorded for the affected lot.The cause of the reported problem was traced to the user manipulation of the device.

• Brand Name: MEDEX
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13586157
• Report Number: 3012307300-2022-03972
• Device Sequence Number: 5817699
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: 10351688507648
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2022

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
• Device Expiration Date: 09/11/2024
• Device Model Number: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 4183215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown