MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-03-07 for TERUMO DENTAL NEEDLE DN-3116KL manufactured by Terumo Corporation - Kofu.
[139342929]
Expiration date - november 2022. Udi - the corresponding lot is not subjected for udi. Implanted date: device was not implanted. Explanted date: device was not explanted. Health professional- unknown. Occupation - unknown. The actual device was returned to the manufacturing facility for evaluation. The actual sample was observed visually, the needle was snapped off at its root. The bend on the snapped fragment was also observed 12mm away from its hub. The damaged portion was closely verified and the cross view of the damage was elliptically deformed. The observation describes that the needle was forcibly tilted and bent once at its root generating dent on glue surface. Due to aforementioned observation, presumption explains that the tube was once bent once closely at its root, then completely snapped as consequence. On the other hand, no scratch or rust which may have degraded overall strength of the needle, was observed. We also examined the actual sample to verify elasticity of flexural strength. Every criterion was checked and through methods regulated by jis standards, and every category has fulfilled the requirement. When reviewing manufacture inspection record of the concerned lot, no irregular records which could have been attributed to any damages to the needle, was pointed out. Furthermore, irregular findings in terms of o. D. And wall thickness in diameter were neither found. Furthermore, we have never been reported of similar events by other medical institutions. The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "do not bend the needle prior to use, as breakage and possible patient injury may result". (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139342930]
The user facility reported that the terumo dental needle shortly snapped off. There was no reported harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681835-2019-00007 |
| MDR Report Key | 8400836 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-07 |
| Date of Report | 2019-03-07 |
| Date Mfgr Received | 2019-02-07 |
| Device Manufacturer Date | 2017-12-05 |
| Date Added to Maude | 2019-03-07 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK VORNHEDER |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | TERUMO CORPORATION - KOFU |
| Manufacturer Street | REG. NO. 9681835 1727-1, TSUIJI-ARAI, SHOWA-CHO |
| Manufacturer City | NAKAKOMA-GUN, YAMANASHI 409-3853 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 409-3853 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO DENTAL NEEDLE |
| Generic Name | NEEDLE, DENTAL |
| Product Code | DZM |
| Date Received | 2019-03-07 |
| Returned To Mfg | 2019-02-07 |
| Model Number | NA |
| Catalog Number | DN-3116KL |
| Lot Number | 171206 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION - KOFU |
| Manufacturer Address | 1727-1, TSUIJI-ARAI SHOWA-CHO NAKAKOMA-GUN, YAMANASHI 409-3853 JA 409-3853 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-07 |