PREHMA DISPOSABLE DENTAL NEEDLES
Received Feb 3, 2023 · Event occurred May 1, 2022
Report 2523320-2023-00001 · MDR key 16296643
Device
Generic name
Dental Needles
Manufacturer
Keystone IndustriesModel number
03-20310Catalog number
03-20310
Lot number
202111300659
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Unknown
- Needle Stick/Puncture
- Needle Stick/Puncture
Narrative
Additional Manufacturer Narrative
A REVIEW OF THE COMPLAINT HISTORY LOG, SHOW ONLY ONE OTHER NEEDLE STICK COMPLAINT IN THE LAST 10 YEARS.
Description of Event or Problem
CUTOMER COMPLAINT WAS RECEIVED ON (B)(6) 2023 RELATING TO A NEEDLE STICK WHILE USING THE DENTAL NEEDLES. THE END USER EXPERIENCED A NEEDLE STICK THROUGH THE NEEDLE CAP DURING OPERATORY CLEAN UP. THE INCIDENT OCCURRED IN (B)(6) 2022 BUT WAS NOT REPORTED JANUARY 2023. AFTER USING THE NEEDLE ON THE PATIENT, THE USER RECAPPED THE NEEDLE AND DURING OPERATORY CLEAN UP, THE NEEDLE POKED THROUGH THE CAP WHICH RESULTED IN A NEEDLE STICK. THE PATIENT WAS IMMUNE COMPROMISED AND THE USER HAD TO TAKE ANTI-RETROVIRAL DRUGS AND RECEIVE PERIODIC BLOOD TESTS. THE USER INDICATED THAT THE SAME INCIDENT HAPPENED AGAIN ON (B)(6) 2023 BUT THE NEEDLE WAS NOT USED. THE USER IS CONCERNED THAT THE NEEDLE IS POKING THROUGH THE SIDE OF THE CAP.
Remedial action
- Patient Monitoring