MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX LARGE BORE - HI-FLO STOPCOCKS; 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	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that about 50-60% of the time this product does not work because it leaks.It will not allow any fluids through once attached to an iv port.Luer lock, strips very easily therefore making it unusable.No patient involvement or patient injury were reported.
Additional Manufacturer Narrative
One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.However, there is evidence that this stopcock may not being used as intended.In the samples returned for this investigation it appears as though the female protector that is placed on the c port has been removed and replaced multiple times and over tightened causing them to shred.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: MEDEX LARGE BORE - HI-FLO STOPCOCKS
• 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: 13169891
• Report Number: 3012307300-2022-00125
• Device Sequence Number: 11229455
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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: 01/21/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/09/2022
• 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