MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-08-09 for NEURO TRACE NEEDLE 553-22-07 manufactured by Neo Medical Inc.
[2791990]
Needle leaks from where syringe connects.
Patient Sequence No: 1, Text Type: D, B5
[10169411]
(b)(4). This report was assessed and determined to be an mdr based on our mdr reporting criteria. F/u will be provided as additional info is received and complaint investigation analysis (b)(4) is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2925153-2012-00004 |
| MDR Report Key | 2702757 |
| Report Source | 07 |
| Date Received | 2012-08-09 |
| Date of Report | 2012-08-09 |
| Date Mfgr Received | 2012-07-12 |
| Device Manufacturer Date | 2012-01-24 |
| Date Added to Maude | 2012-08-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 42514 ALBRAE ST |
| Manufacturer City | FREMONT CA 94538 |
| Manufacturer Country | US |
| Manufacturer Postal | 94538 |
| Manufacturer Phone | 8884503334 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURO TRACE NEEDLE |
| Generic Name | NEURO TRACE NEEDLE |
| Product Code | BXN |
| Date Received | 2012-08-09 |
| Returned To Mfg | 2012-08-03 |
| Model Number | 553-22-07 |
| Catalog Number | 553-22-07 |
| Lot Number | 0163 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEO MEDICAL INC |
| Manufacturer Address | FREMONT CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-09 |