MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX SMALL BORE STOPCOCKS; 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record review.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.G5 is unknown.
Event or Problem Description
It was reported that a 4-way stopcock kept disconnecting from the iv line; the nurse had 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
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: 3012307300-2022-26313.The report was submitted in error.

• Brand Name: MEDEX SMALL BORE 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; hsc-wr0; minneapolis, MN 55442
• MDR Report Key: 15677094
• Report Number: 3012307300-2022-26313
• Device Sequence Number: 6348643
• 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: 10/26/2022
• 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