AR-13991N @SUREFIRE SCORPION NDL
Received Dec 23, 2020 · Event occurred Dec 1, 2020
Report 3032391-2020-00016 · MDR key 11065063
Device
Product problems
- Break
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT MULTIPLE NEEDLES BROKE DURING USE WITH A PATIENT DURING THE SAME PROCEDURE. THE PROCEDURE IS REPORTEDLY UNKNOWN. THE FACILITY WAS ABLE TO RETRIEVE ALL OF THE NEEDLES AND DISPOSED OF THEM IN A SHARPS CONTAINER. NO ACTUAL SAMPLE IS AVAILABLE TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE AND NO EFFECT ON THE PATIENT'S STABILITY AS A RESULT OF THE INCIDENT. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT MULTIPLE NEEDLES BROKE DURING USE WITH A PATIENT DURING THE SAME PROCEDURE.