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

Catalog Number MX2311L

Patient Problem Chemical Exposure (2570)

Event Date 10/09/2023

Event Type  malfunction  

Event Description

While delivering intraarterial 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 2 persons.2 physicians received splatter on their sterile gown, lead apron, face, and hair.Staff provided new products and the procedure completed without further incident and with no known harm to the patient.Product: smiths medical medex ultra(tm) 3-way stopcock w/ swivel male luer lock.Ref#(b)(4), lot#4391454.

• Brand Name: MEDEX
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17949580
• MDR Text Key: 326013674
• Report Number: MW5147016
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White