MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2019-05-15 for ULTRA SAFETY PLUS SHORT NEEDLE 30G 25MM manufactured by Septodont.
[145106579]
Manufacturer investigation results: investigation was performed on batch f51363aa. This was the first complaint received for this defect on this cannula batch for the (b)(4) assembled cannulas including (b)(4) on this batch of needle guards. The controls set up by our cannula supplier and during internal production allow to avoid the risk of providing defective cannulas. In addition, during the tests carried out, no defect could be observed on the needles tested on the concerned batch: no needle breakage occurred during the bending tests with strength greater than 22n. In the absence of recurrence recorded for this type of issue on this batch, of defect retrieved during tests performed, and considering presumption of misuse by the practitioner, the residual risk was considered acceptable. The cause of the reported issue could not be determined exactly but the conditions of the anesthesia and presumption of misuse by the practitioner remained the preferred cause. Therefore, and in the absence of recurrence of this issue on this batch, no corrective action will be set up. Final comments from manufacturer: no abnormality, nor maintenance intervention that could have an impact on the quality of the product were identified during production of the batch. Moreover, no defect were found during quality tests and as the practitioner did not provide the device concerned by the complaint nor the needle guards from the concerned box, the cause of the defect could not be determined. The cause of improper use by the practitioner cannot be ruled out: folding of the cannula before injection or excessive pressure having caused too much stress on the cannula during the injection or sudden movement of the cannula needle during injection. The nervous state of the patient at the time of injection may also have an impact on the conditions of the anesthesia. Good practices for the use of needle guards are listed in the package leaflet. A review of the good use of the products is recommended to the practitioner.
Patient Sequence No: 1, Text Type: N, H10
[145106580]
Spontaneous report from (b)(6). Local reference # (b)(4). Initial information received on (b)(6) 2019 from a dentist by phone. Follow-up #1 received on (b)(6) 2019 with the adverse incident report from (b)(6), ref: (b)(4); (b)(6) ref: (b)(6)). The dentist reported that a patient (unspecified gender), with no specified medical history had been treated with ultra safety plus 30g short (batch number : f51363aa, exp sep2023) on (b)(6) 2019. On the same date, needle broke in two (not at the hub) whilst in the patient's mouth during an infiltration for local anaesthesia prior to extraction on ur1. Broken pieces were retrieved and the treatment was carried out for the patient without any issues and no harm to patient or practitioner. There was no injury to the patient with this incident. The broken needle was kept until reporting. All needles of this particular batch number in the possession of the dentist have been removed from use by the dentist until further notice. Photograph of the broken needle was provided for reference. At the time of the report, the patient's outcome was recovered. Investigation report information concluded as follows: no defects were found during quality tests on the needles of the concerned batch and as the practitioner did not provide the device concerned by the complaint nor the needle guards from the concerned box, the cause of the defect could not be determined. The cause of improper use by the practitioner cannot be ruled out: folding of the cannula before injection or excessive pressure having caused too much stress on the cannula during the injection or sudden movement of the cannula needle during injection. The nervous state of the patient at the time of injection may also have an impact on the conditions of the anesthesia. In the absence of recurrence of this issue on this batch, no corrective action will be set up. Follow-up #1 received on (b)(6) 2019: (b)(6) reference, needle broken details and remedial action taken were added. Primary source information (hcp information) and outcome were modified. Follow-up #2 received on (b)(6) 2019: investigation report information has been added. Follow-up #3 received on 30-apr-2019: duplicate reference (b)(6): (b)(4) (number allocated to the report received direct from the reporter). Causality assessment on 24-apr-2019 on initial information received on (b)(6) 2019 and additional information received on (b)(6) 2019 and on (b)(6) 2019: causality assessment on 14-may-2019 on additional information received on (b)(6) 2019: seriousness: serious for septodont (required intervention to prevent permanent impairment/damage (devices)). Expectedness: needle issue: unexpected eu/us, no adverse event: expected eu/us. Causality: latency: compatible, recognized association: no. Analysis - a dentist reported needle breakage while using the device in a patient. At the time of this report, information are not sufficient to identify a misuse or inappropriate usage during the local injection. However, as quality investigations retrieved no defect on the batch of the device, the preferred cause may be bending of the needle before use, excessive pressure or movement of the needle during injection, a sudden movement of the patient during injection or the use of a needle size inappropriate to the type of procedure. Therefore, the causality between the device and these events was assessed as unlikely. Concluded causality who: unlikely.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610964-2019-00003 |
| MDR Report Key | 8611705 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2019-05-15 |
| Date of Report | 2019-05-15 |
| Date of Event | 2019-04-15 |
| Date Mfgr Received | 2019-04-18 |
| Date Added to Maude | 2019-05-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 58, RUE DU PONT DE CRETEIL |
| Manufacturer City | SAINT MAUR DES FOSSESS, 94107 |
| Manufacturer Country | FR |
| Manufacturer Postal | 94107 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA SAFETY PLUS |
| Generic Name | ULTRA SAFETY PLUS |
| Product Code | DZM |
| Date Received | 2019-05-15 |
| Model Number | SHORT NEEDLE 30G 25MM |
| Lot Number | F51363AA |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEPTODONT |
| Manufacturer Address | 58, RUE DU PONT DE CRETEIL SAINT MAUR, CEDEX VAL-DE-MARNE, 94107 FR 94107 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-15 |