MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-02 for 30 G SHORT PLASTIC 8881400074 manufactured by Covidien.
[59349300]
An investigation is currently underway; upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[59349301]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dental needle. The customer states the needles are defective because the metal parts separate from the tips, and fall to the ground.
Patient Sequence No: 1, Text Type: D, B5
[120563006]
An investigation of the reported condition was performed. The review of device history record (dhr) indicates that no issues were found for the reported lot. The review of maintenance and calibration records, machine set up, process monitoring data detected no issues. All scheduled maintenance and calibration activities were completed on time. There were no process or material changes that have occurred for the reported condition. The current state of the machine was found to be operating normally. The samples were not returned for evaluation. The reported condition could not be confirmed. Should the sample be returned, the compliant can be reopened. The exact root cause of the reported condition could not be determined without an actual sample. With the little evidence available, the most probable root cause could not be determined as well. Prior to a lot release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan. Inspectors routinely examine a statistical sample both physically and visually. Specifically, visual inspection is performed for correct assembly and pull tested for cannula to hub security. The lot released met all defined acceptance requirements. No corrective and preventive actions are deemed necessary now. This information will be utilized for trending purposes to determine the need for corrective actions. The production department will be notified about incident with a copy of this complaint response. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017768-2016-00099 |
| MDR Report Key | 6073157 |
| Date Received | 2016-11-02 |
| Date of Report | 2016-10-06 |
| Date Mfgr Received | 2016-10-06 |
| Date Added to Maude | 2016-11-02 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2010 EAST INTERNATIONAL SPEEDWAY BLVD. |
| Manufacturer City | DELAND FL 32720 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32720 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 30 G SHORT PLASTIC |
| Generic Name | DENTAL NEEDLE |
| Product Code | EJI |
| Date Received | 2016-11-02 |
| Model Number | 8881400074 |
| Catalog Number | 8881400074 |
| Lot Number | 529921 |
| 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 SPEEDWAY BLVD. DELAND FL 32720 US 32720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-02 |