MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,user facility report with the FDA on 2019-01-07 for 401 DENTAL NDL 30SH 8881401072 manufactured by Covidien.
[132244331]
The incident sample has been requested but to date has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[132244332]
The customer states: while numbing a (b)(6) female patient for a lower mandibular block, the needle broke off into the patient's tissue. The patient had to go to an oral surgeon to remove the piece and it still has not been removed fully. The patient currently is doing ok, but still has a piece of the needle in her tissue. Upon follow up on 7-jan-2018, the customer stated that the needle detached completely at the hub. The needle was not bent prior to use. The needle detached during the first use. The needle is still inside the patient. The patient will need to go to the oral surgeon again to have it removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017768-2019-00548 |
| MDR Report Key | 8222679 |
| Report Source | DISTRIBUTOR,USER FACILITY |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-12-18 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-01-07 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524970 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2010 EAST INTERNATIONAL SPEEDW |
| Manufacturer City | DELAND FL 32724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 401 DENTAL NDL 30SH |
| Generic Name | NEEDLE, DENTAL |
| Product Code | DZM |
| Date Received | 2019-01-07 |
| Model Number | 8881401072 |
| Catalog Number | 8881401072 |
| Lot Number | 818010 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2010 EAST INTERNATIONAL SPEEDW DELAND FL 32724 US 32724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-07 |