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

Model Number MX9311L

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Loss of consciousness (2418)

Event Date 07/17/2023

Event Type  Injury  

Event Description

The stopcock attached to the proximal port of a central venous catheter (cvc) being used for central venous pressure (cvp) monitoring became disconnected while the patient was transferred to the commode resulting in the patient passing out and requiring intubation.There was no loss of pulse however the patient was later diagnosed with a stroke as a result of a venous air embolus.

• Brand Name: MEDEX
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• MDR Report Key: 17469078
• MDR Text Key: 320485723
• Report Number: 17469078
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: MX9311L
• Device Catalogue Number: MX9311L
• Device Lot Number: 4259404
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2023
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability; Other
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White