D
Patient 1
SPONTANEOUS REPORT, FROM THE US. (B)(4). INITIAL INFORMATION WAS RECEIVED BY DEALER ON (B)(6) 2019 FROM REPORTING DENTAL OFFICE AND FORWARDED TO SEPTODONT ON (B)(4) 2019. ON (B)(6) 2019, SUSPECT DEVICE HENRY SCHEIN STANDARD NEEDLES 30GA SHORT (BATCH # AND EXPIRATION DATE: NOT SPECIFIED) REPORTEDLY BROKE OFF AT THE HUB WHILE IN A PEDIATRIC PATIENT'S MOUTH. THE NEEDLE INVOLVED REPORTEDLY WAS CAUGHT IN TIME TO BE REMOVED AND THE PATIENT WAS NOT INJURED. ADDITIONAL INFORMATION IS EXPECTED. CAUSALITY ASSESSMENT ON (B)(4) 2019 INITIAL INFORMATION RECEIVED ON (B)(4) 2019: SERIOUSNESS: SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)). EXPECTEDNESS: DEVICE BREAKAGE: UNEXPECTED US/CA. CAUSALITY: LATENCY - COMPATIBLE, RECOGNIZED ASSOCIATION - NO, ANALYSIS - THIS CASE REPORTED A BREAK AT THE HUB OF THE SUSPECTED DEVICE HENRY SCHEIN STANDARD NEEDLES 30GA SHORT, REQUIRING DENTIST INTERVENTION TO REMOVE THE BROKEN PART. THE POSSIBLE CAUSES OF BROKEN NEEDLE MAY RESULT FROM: INVOLUNTARY SUDDEN MOVEMENT OF THE PATIENT, ESPECIALLY BECAUSE IT IS A PAEDIATRIC PATIENT; INVOLUNTARY MOVEMENT OR MISHANDLING OF THE DENTIST DURING INJECTION; THE USE OF A NEEDLE SIZE INAPPROPRIATE TO THE TYPE OF PROCEDURE; UNEXPECTED CONTACT WITH HARD TISSUES (E.G. BONE); EXCESSIVE BENDING OF THE NEEDLE BEFORE USE OR DURING USE BY THE DENTIST; EXCESSIVE PRESSURE LEADING TO A BREAK OF THE NEEDLE; QUALITY DEFECT OF THE NEEDLES; THE METHOD USED FOR THE ANAESTHESIA AND THE DENTAL PROCEDURE ARE NOT SPECIFIED. SINCE THIS CASE IS POORLY DOCUMENTED, NO SUFFICIENT INFORMATION IS PROVIDED TO EXPLAIN THE BROKE OF THE NEEDLE AT THE HUB IN THE PATIENT'S MOUTH. INVESTIGATION TESTS ARE PENDING. THEREFORE, DUE TO THE LACK OF DATA, THIS CASE IS CONSIDERED AS NOT ASSESSABLE. CONCLUDED CAUSALITY WHO: NOT ASSESSABLE.