MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-05-24 for NEURO TRACE 553-22-07 manufactured by Neo Medical, Inc..
[2791225]
Neuro trace needle reported by end user to have a hole between needle and extension. Air going through where the hub and extension meet.
Patient Sequence No: 1, Text Type: D, B5
[9891606]
(b)(4). This report was assessed and determined and determined to be an mdr based on our mdr reporting criteria. Follow up will be provided as additional information is received and complaint investigation analysis ((b)(4)) is completed pending device being returned by end user.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2925153-2012-00001 |
| MDR Report Key | 2596223 |
| Report Source | 07 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-05-23 |
| Date of Event | 2012-04-25 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2012-08-03 |
| 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 STREET |
| 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 |
| Generic Name | NEURO TRACE NEEDLE |
| Product Code | BXN |
| Date Received | 2012-05-24 |
| Model Number | 553-22-07 |
| Catalog Number | 553-22-07 |
| Lot Number | 0163 |
| Device Expiration Date | 2012-01-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEO MEDICAL, INC. |
| Manufacturer Address | FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-24 |