[143237915]
Spontaneous report, from (b)(6). Local reference # (b)(4). Quality complaint file was opened; local complaint reference # (b)(4). Quality complaint: # (b)(4). Initial information received by the manufacturer from the (b)(6) on 10-jan-2019 (reference # (b)(4)) reporting information from dental office. The same report was received from (b)(6) on 15-jan-2019. Incident reporting form received on 25-feb-2019 from the dentist. On 22-nov-2019 (noted in incident reporting form but 29-nov-2018 in the (b)(6) report), dental student administered a local anesthetic (trade name not specified) with the suspect device ultra safety plus needle blue 30ga (batch # f51257aa and expiration date: mar-2023). Needle broke on 3 occasions and was withdrawn from patients mouth. No injury was reported. The patients were reassured and all needles from the same batch were withdrawn from clinic. The patients recovered and the dentist did not considered this incident as serious. Additional information is expected. Causality assessment on 28-mar-2019 on initial information received on 10-jan-2019 and on additional information received on 25-feb-2019: seriousness: serious. Expectedness: needle issue: unexpected eu/ca/us. No adverse event: expected eu/ca/us. Causality: latency: compatible. Recognized association: no. Analysis - a dental student reported needle breakage while using the device in patients. The possible causes for the reported event may be the bending of the needle before use, excessive pressure or movement of the needle during injection, a sudden movement of the patient during injection, the use of a needle size inappropriate to the type of procedure and/or quality defect of the needle. At the time of this report, information are not sufficient to identify a misuse or inappropriate usage during the local injection and to conclude. Quality investigation is ongoing; pending the results, the case report was considered as not assessable. Concluded causality who: not assessable.
Patient Sequence No: 1, Text Type: D, B5