MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-04-02 for TERUMO DENTAL NEEDLE DN-3116KL manufactured by Terumo Corporation - Kofu.
[140935113]
Date of event: requested, not provided. 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. Initial reporter occupation - unknown. The actual device has been returned to the manufacturing facility for evaluation. The actual sample was closely verified, the needle was snapped off at its root as initially reported. However the needle fragment was not obtained. 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 a dent on the glue surface. Due to the aforementioned observation, presumption explains that the tube was once bent closely at its root, and then completely snapped off as consequence. There was no scratch's or rust which may have degraded overall strength of the needle was observed. Furthermore, the needle dimension was checked and no irregularity were observed. When reviewing manufacture inspection record of the concerned lot, no irregular records which could have been attributed to any damages to the needle, were found. Furthermore, no similar events reported by other medical institutions, have never been made. 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
[140935114]
The user facility reported that a terumo dental needle was damaged. This occured pre-treatment. No health hazaeds were incurred on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681835-2019-00009 |
| MDR Report Key | 8475964 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-04-02 |
| Date of Report | 2019-04-02 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2017-12-05 |
| Date Added to Maude | 2019-04-02 |
| 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 | THERESA MUSSAW |
| 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 | 2019-04-02 |
| Returned To Mfg | 2019-03-04 |
| 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 | 2019-04-02 |