MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX ULTRA 4-WAY STOPCOCK W/SWIVEL MALE LUER; STOPCOCK, I.V. SET

Model Number	MX2341L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product returned and no photos were provided by the customer for investigation of the reported complaint.The complaint cannot be confirmed.Device history record and inspection paperwork were reviewed and found no indication of issues with the parts tested during the production run.Maintenance work order history was also reviewed and found no reported maintenance work done during the time frame that the lot was produced.On hand quantity has been reviewed and found no stock remaining on hand.Complaint data was also reviewed and found one other complaint in the last two years that could not be verified due to no product being returned and no photos being provided.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.Pma/510(k) number: unknown.
Event or Problem Description
It was reported that the 4- way stopcock kept disconnecting from the iv line although the nurse screwed it in securely.There has been no report of patient involvement or no observable clinical symptoms or a change in symptoms identified in the patient.
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Please disregard the initial report submitted with the mfr number: 3012307300-2022-26332.The report was submitted in error.Corrected data: corrected information provided in h10.

• Brand Name: MEDEX ULTRA 4-WAY STOPCOCK W/SWIVEL MALE LUER
• 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; hsc-wr0; minneapolis, MN 55442
• MDR Report Key: 15679554
• Report Number: 3012307300-2022-26332
• Device Sequence Number: 12386533
• Product Code: FMG
• UDI-Device Identifier: 10351688508324
• UDI-Public: 10351688508324
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2023

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: 03/01/2025
• Device Model Number: MX2341L
• Device Catalogue Number: MX2341L
• Device Lot Number: 4262614
• Was Device Available for Evaluation?: No
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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 Sex: Unknown