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

Catalog Number MX2311L

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Leak/Splash (1354); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

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 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.

Manufacturer Narrative

Other, other text: d3, g1, and g2 email is: regulatory.Responses@icumed.Com additional information: b5.

Event Description

Additional information was received: it was stated that there was no medical intervention.

• Brand Name: MEDEX 3-WAY STOPCOCK
• Type of Device: 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
• MDR Text Key: 328565922
• Report Number: 3012307300-2023-10636
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 10351688508331
• UDI-Public: 10351688508331
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX2311L
• Device Lot Number: 4391454
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 98 KG
• Patient Race: White