NEOTECH PRODUCTS
Received Jun 10, 2021
Report 2025917-2021-00005 · MDR key 11974562
Device
Product problems
- Loss of or Failure to Bond
- Loss of or Failure to Bond
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE WAS NOT RETURNED AND NO EVALUATION WAS POSSIBLE ON THE ACTUAL DEVICE. HOWEVER, SAMPLES OF FINISHED GOODS WERE PULLED OUT FROM RETAINED SAMPLES OF BOTH REPORTED AND CURRENT LOT NUMBERS FOR RE-INSPECTION AND NO ABNORMALITY WAS FOUND. ALSO, THE PRODUCT'S DEVICE HISTORY RECORDS (DHR) OF REPORTED LOT AND CURRENT INVENTORY WERE REVIEWED AND NO NONCONFORMITY WAS FOUND. PER OUR INVESTIGATION DEVICE WAS USED WITH RAM CANNULA AND ON OFF LABEL USE FOR CPAP. THIS COULD BE CONTRIBUTED TO THESE ISOLATED INCIDENTS AS WE JUST HAD ONE SIMILAR INCIDENT FROM THE SAME SOURCE IN THE PAST FIVE YEARS FOR MILLIONS OF THE PARTS THAT WERE USED ALL AROUND THE WORLD. PER COMPLAINTS RATIO, THESE INCIDENTS WERE ISOLATED EVENTS. THIS COMPLAINT WILL BE MONITORED FOR TRENDING PURPOSES AND IS ADDED TO THE RELATED LOGS AND CHARTS.
Description of Event or Problem
PER CUSTOMER, NEOSEAL FOUND IN BABY'S MOUTH BUT WAS REMOVED IN TIME.
Remedial action
- Inspection