MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX 4-WAY STOPCOCK; STOPCOCK I.V. SET

Catalog Number	MX2341L
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a particle of component in the device.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Additional Manufacturer Narrative
The sample was released from manufacturing on 03feb25 with 29400 parts.There was 1 ncmr generated during the manufacturing process that involved shelling out and repackaging and no complaint trending identified on this lot or part number.From the inspection, cardboard lpm was observed in 12/80 samples failed for lpm in packaging, meeting the rejection threshold.Therefore, the defect is confirmed for lpm.

• Brand Name: MEDEX 4-WAY STOPCOCK
• Common Device Name: STOPCOCK I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 22027049
• Report Number: 1526863-2025-00054
• Device Sequence Number: 15734685
• Product Code: FMG
• UDI-Device Identifier: 10351688508324
• UDI-Public: (01)10351688508324(17)271216(10)6078224
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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 Catalogue Number: MX2341L
• Device Lot Number: 6078224
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2025
• Supplement Date Received by Manufacturer: 01/25/2026
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown