MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-17 for TERUMO DENTAL NEEDLE DN-3021KL manufactured by Terumo Corporation - Kofu.
[124093978]
Expiration date - august 2021. Udi - the corresponding lot is not subjected for udi. Implanted date: device was not implanted. Explanted date: device was not explanted. (b)(6). (b)(4). Two actual device pieces and 112 unused samples were returned to the manufacturing facility for evaluation. Visual inspection of the two pieces revealed that both tubes were snapped at its root, and a bend was observed at the center. Damaged portion was closely verified and the cross view of the damage was elliptically deformed. The observation describes that both tubes were forcibly tilted and bent once at its root generating a dent on the glue surface. Due to aforementioned observations, presumption explains that the tubes were bent once closely at its root, then completely snapped off as consequence. No scratches or rust were observed. The 112 unused samples of the same lot were visually checked and no irregularities including physical bent, deformation or uneven thickness, were observed. The 112 unused samples of the same lot were examined to verify elasticity of flexural strength. Every criterion was checked and through methods regulated by (b)(4)standards and every category has fulfilled the requirement. We reviewed the manufacture inspection record of the concerned lot, but no abnormal records which could be attributed to any damage to tubes, were noted. No irregular finding were observed in terms of o. D. And wall thickness of the needle. 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
[124093979]
The user facility reported that the needle snapped at its root while penetrating into the gum. There was no reported health hazard to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681835-2018-00030 |
| MDR Report Key | 7973483 |
| Date Received | 2018-10-17 |
| Date of Report | 2018-10-17 |
| Date of Event | 2018-09-11 |
| Date Mfgr Received | 2018-09-19 |
| Device Manufacturer Date | 2016-09-22 |
| Date Added to Maude | 2018-10-17 |
| 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 | 0 |
| Brand Name | TERUMO DENTAL NEEDLE |
| Generic Name | NEEDLE, DENTAL |
| Product Code | DZM |
| Date Received | 2018-10-17 |
| Returned To Mfg | 2018-09-19 |
| Model Number | NA |
| Catalog Number | DN-3021KL |
| Lot Number | 160921 |
| 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 | 2018-10-17 |