Description of Event or Problem · 1
SPONTANEOUS REPORT. LOCAL REFERENCE # (B)(4). INITIAL INFO RECEIVED BY SEPTODONT INC. ON (B)(6) 2015. ADD'L INFO WAS RECEIVED BY SEPTODONT INC. ON B)(6) 2015. THE DENTIST REPORTED AN INCIDENT INVOLVING SUSPECT MEDICAL DEVICE QUALA PRIVATE LABEL 30G SHORT NEEDLE (BATCH #F02643AB; EXPIRATION DATE: 03/2019). ON B)(6) 2015, THE DENTIST USED THE SUSPECT MEDICAL DEVICE ON A HEALTHY MALE PT AGED B)(6) FOR A CONVENTIONAL RIGHT MANDIBULAR BLOCK FOR A DENTAL PROCEDURE CROWN ON TEETH # 31 DUE TO RECURRENT TOOTH DECAY. THE PT HAS NO KNOWN ALLERGIES, WAS NOT ANXIOUS PRIOR TO THE DENTAL PROCEDURE AND THE INJECTION SITE WAS HEALTHY AT THE TIME OF INJECTION. NO CONCOMITANT MEDICATION INFO WAS REPORTED. THE PT DID NOT EXPERIENCE ANY DISCOMFORT AT THE TIME OF USE OF THE SUSPECT MEDICAL DEVICE. PER REPORTING DENTIST THE NEEDLE BROKE AFTER THE BLOCK, WHICH WAS NOTICED AFTER THE DENTIST PULLED THE SYRINGE OUT AND REALIZED THAT THE NEEDLE WAS NOT PRESENT. X-RAYS (TYPE UNSPECIFIED) WAS DONE ON THE SAME DAY (B)(6) 2015) AND CONFIRMED THE NEEDLE PRESENT IN THE PT'S MOUTH. ON B)(6) 2015, THE PT WAS SENT OVER TO AN ORAL SURGEON FOR THE REMOVAL OF THE BROKEN NEEDLE, AND THE SURGEON REMOVED THE NEEDLE THE SAME DAY WITHOUT ANY APPARENT COMPLICATIONS. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. THE REPORTING DENTIST IS CONCERNED WHY THIS EXACTLY HAPPENED, AND WHETHER A POSSIBILITY EXISTS THAT THE SUSPECT PRODUCT WAS A DEFECTIVE LOT OR A BATCH THAT THE SUSPECT MEDICAL DEVICE BELONGED TO. INFO ON THE TYPE OF LOCAL ANESTHETIC USED WAS NOT PROVIDED. NO SAMPLE IS AVAILABLE FOR INVESTIGATION AS THE NEEDLE INVOLVED HAS ALREADY BEEN DISCARDED. THE ADVERSE EVENT HAS BEEN REPORTED RESOLVED BY THE REPORTING DENTIST AS OF B)(6) 2015. MEDICAL REVIEW ON B)(6) 2015 AND B)(6) 2015 BY MM: SERIOUSNESS - SERIOUS; EXPECTEDNESS - NEEDLE ISSUE, UNEXPECTED US; CAUSALITY - A SHORT NEEDLE BROKE DURING A RIGHT MANDIBULAR BLOCK. THE REPORTING DENTIST NOTICED THE BREAKAGE WHEN HE PULLED THE SYRINGE OUT AND REALIZED THAT THE NEEDLE WAS NOT THERE, CONFIRMED WITH X-RAYS AND SENT PT OVER TO AN ORAL SURGEON THE NEXT DAY FOR REMOVAL. THE SURGEON REMOVED THE NEEDLE ON B)(6) 2015 WITHOUT ANY APPARENT COMPLICATIONS. THE POSSIBLE CAUSES OF BREAKAGE NEEDLES ARE: POSSIBLE INVOLUNTARY MOVEMENT OF THE PT, POSSIBLE MOVEMENT OF NEEDLE, CONTACT WITH HARD TISSUES (BONE), EXCESSIVE PRESSURE CHANGING THE RESISTANCE OF NEEDLE DURING INJECTION. CAUSALITY WHO: NO RELATED BY LACK OF INFO. REF MFR #: 3002987375-2015-00002.