MalfunctionKCP
VANTG METAL EAR SYRINGE 4
Received Jul 16, 2012
Report 2523190-2012-00062 · MDR key 2662539
Device
Product problems
- Detachment Of Device Component
- Device Operates Differently Than Expected
Patient
Not reported
- Perforation
Narrative
Description of Event or Problem
THE CUSTOMER INITIALLY REPORTS THAT DURING IRRIGATION OF PT'S EAR WITH WATER, THE END CAP CAME OFF ITS THREADS. IN THE PROCESS, TIP WAS INSERTED INTO PT'S EAR CANAL PIERCING HER TYMPANIC MEMBRANE. SYRINGE WAS NEARLY NEW AND THREADS HAD FAILED. ON (B)(6) 2012, THE CUSTOMER WAS RELUCTANT TO PROVIDE ANY FURTHER INFO AND REPORTS THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.