D
Patient 1
SPONTANEOUS REPORT, FROM THE US. LOCAL REFERENCE # (B)(4). QUALITY COMPLAINT FILE WAS OPENED; REFERENCE # (B)(4). LINKED WITH LOCAL REFERENCE # (B)(4) (SAME REPORTER, SAME SUSPECT DEVICE, DIFFERENT IDENTIFIABLE PATIENT). INITIAL INFORMATION RECEIVED ON (B)(6) 2018; FOLLOW-UP #1 INFORMATION WAS RECEIVED ON (B)(6) 2018; FOLLOW-UP #2 INFORMATION WAS RECEIVED ON (B)(6) 2018. INITIAL, FOLLOW-UP #1, AND FOLLOW-UP #2 INFORMATION RECEIVED ARE INTEGRATED IN BELOW CASE NARRATIVE. THE SUSPECT DEVICE HENRY SCHEIN PREMIUM 30GA SHORT NEEDLES (BATCH #1: F04497AA, EXPIRATION DATE: 2020-10; BATCH #2: F07144AA, EXPIRATION DATE: 2023-02) WAS USED FOR A LONG BUCCAL INJECTION DURING A DENTAL FILLING PROCEDURE ON AN ADULT PATIENT (GENDER AND AGE UNSPECIFIED), ON (B)(6) 2018. THE SYRINGE TYPE USED WAS SCREW-ON TYPE. NO ISSUES WERE REPORTED WHILE SCREWING THE SUSPECT NEEDLE ONTO THE SYRINGE. ON (B)(6) 2018, DURING THE INJECTION, THE HUB AND THE NEEDLE "CANNUAL" DISCONNECTED, WITH THE NEEDLE HUB "STAY" CONNECTED TO THE SYRINGE WHILE THE WHOLE NEEDLE "CANNUAL" STAYED BEHIND IN THE PATIENT. NO NEEDLE WAS REPORTED BROKEN. THE DENTIST WAS ABLE TO RETRIEVE THE NEEDLE FROM THE PATIENT'S MOUTH. NEEDLE SAMPLES WERE EXPECTED TO BE RETURNED FOR INVESTIGATION. CAUSALITY ASSESSMENT ON 08-OCT-2018 ON INITIAL INFORMATION AND ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 AND FOLLOW-UP INFORMATION RECEIVED ON (B)(6) 2018 AND (B)(6) 2018: SERIOUSNESS: SERIOUS (REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES)). EXPECTEDNESS: FOREIGN BODY IN GASTROINTESTINAL TRACT: UNLISTED EU, UNEXPECTED US/CA; NEEDLE ISSUE: UNLISTED EU, UNEXPECTED US/CA. CAUSALITY: LATENCY: SUGGESTIVE. RECOGNIZED ASSOCIATION: NO. ANALYSIS: IN THIS CASE, THE CANNULA OF THE NEEDLE HAS DETACHED FROM THE HUB DURING A LONG BUCCAL INJECTION. QUALITY INVESTIGATION IS ONGOING. AT THE TIME OF THIS REPORT, INFORMATION WAS NOT SUFFICIENT TO ALLOW A CAUSALITY ASSESSMENT. PENDING THE RESULTS OF QUALITY CONTROL, THE CASE REPORT WAS CONSIDERED AS NOT ASSESSABLE. DECHALLENGE: NA. RECHALLENGE: NA. CONCLUDED CAUSALITY WHO: NOT ASSESSABLE.