MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX 3-WAY STOPCOCK; STOPCOCK I.V. SET

Catalog Number	MX2311L
Medical Device Problem Codes	Disconnection (1171); Fluid/Blood Leak (1250); Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: g5: 510k is blank, device is exempt.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.
Event or Problem Description
It was reported that while delivering intra arterial chemo with a 3ml syringe on a lipid-resistant 3-way stopcock through a microcatheter, the side chamber of the stopcock was "blown off" resulting in a chemo spill across the sterile drape, floor, and two persons.Physicians received splatter on their sterile gown, lead apron, face, and hair.Staff provided new products and the procedure completed without further incident.No patient injury or clinical affects was reported.
Additional Manufacturer Narrative
Other, other text: d3, g1, and g2 email is: regulatory.Responses@icumed.Com additional information: b5.
Event or Problem Description
Additional information was received: it was stated that there was no medical intervention.

• Brand Name: MEDEX 3-WAY STOPCOCK
• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 18173577
• Report Number: 3012307300-2023-10636
• Device Sequence Number: 15375465
• Product Code: FMG
• UDI-Device Identifier: 10351688508331
• UDI-Public: 10351688508331
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2024

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: 04/18/2026
• Device Catalogue Number: MX2311L
• Device Lot Number: 4391454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 11/09/2023; 04/18/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/05/2023; 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• 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: 54 YR
• Patient Sex: Unknown
• Patient Weight: 98 KG
• Patient Race: White