MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX INFUSION EXTENSION SETS; SMALL BORE 4-WAY STOPCOCK STANDARD BORE EXTENSION

Model Number	MX522SL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stopcock w/extension was being used to administer cellular therapy products and when removed from the lumen it was hooked into, part of the end of the male piece stayed in the patient's lumen and caused the line to be replaced.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: MEDEX INFUSION EXTENSION SETS
• Common Device Name: SMALL BORE 4-WAY STOPCOCK STANDARD BORE EXTENSION
• 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: 15008632
• Report Number: 3012307300-2022-13324
• Device Sequence Number: 6781408
• Product Code: FPA
• UDI-Device Identifier: 10351688506818
• UDI-Public: 10351688506818
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/17/2025
• Device Model Number: MX522SL
• Device Catalogue Number: MX522SL
• Device Lot Number: 4244298
• Was Device Available for Evaluation?: No
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 79 KG