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	12/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stopcock leaks fluid that passed through it.There was no patient injury reported.
Additional Manufacturer Narrative
One stop-cock was received for evaluation in relation to the reported event.Functional and visual inspection determined that the reported leaking was coming from the b port where the protector is located that is used for shipping and protection purposes.It appears as though the customer was 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.The reported event was confirmed and replicated, and the root cause was determined to be the customer utilizing a protector as a plug instead of the appropriate plug intended for this use.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Additional Manufacturer Narrative
Other, other text: one stop-cock was received for evaluation in relation to the reported event.Functional and visual inspection determined that the reported leaking was coming from the b port where the protector is located that is used for shipping and protection purposes.It appears as though the customer was 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.The reported event was confirmed and replicated, and the root cause was determined to be the customer utilizing a protector as a plug instead of the appropriate plug intended for this use.A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Additional Manufacturer Narrative
Other, other text: corrected data: b1, corrected data: corrected data: b1 - product problem.

• 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): NULL; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13507367
• Report Number: 3012307300-2022-03139
• Device Sequence Number: 14471514
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2023

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 Expiration Date: 09/13/2024
• Device Model Number: MX4341L
• Device Catalogue Number: MX4341L
• Device Lot Number: 4195704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/08/2022; 06/14/2023
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 03/09/2022; 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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