BIVONA CUSTOMIZED TRACHEOSTOMY TUBE
Received Jun 29, 2020
Report 3012307300-2020-06371 · MDR key 10210352
Device
Generic name
Airway, Esophageal (obturator)
Product problems
- Disconnection
- Material Fragmentation
- Detachment of Device or Device Component
- Disconnection
- Material Fragmentation
- Detachment of Device or Device Component
Patient
14 MO
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
OTHER, OTHER TEXT: ONE OBTURATOR WAS RETURNED FOR ANALYSIS. THE HANDLE WAS NOTED TO BE DETACHED FROM THE OBTURATOR WIRE UPON VISUAL INSPECTION. THERE WAS ALSO ADHESIVE VISIBLE ON THE OBTURATOR HANDLE AND INSIDE THE OBTURATOR HANDLE HOLE. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED AS THERE WAS NO PART NUMBER OR LOT NUMBER PROVIDED. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED. HOWEVER, THE ROOT CAUSE IS UNKNOWN. ALSO, SEEING THAT THE COMPLAINT IS SPECIFICALLY ON THE OBTURATOR ITSELF, THE PRODUCT CODE WAS UPDATED.
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING A ROUTINE CHANGE OUT OF A SMITHS MEDICAL BIVONA CUSTOMIZED TRACHEOSTOMY TUBE, THE METAL INTRODUCER HAD BECOME DISCONNECTED FROM THE HUB. IT WAS THOUGHT THAT THE TECHNICIAN DID NOT PUT THE INTRODUCERS INTO THE AUTOCLAVE TO SET THE ADHESIVE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.