MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2018-10-29 for BD SPINAL ? NEEDLE 26GA 3-1/2IN 408380 manufactured by Becton Dickinson Industrias Cirurgicas, Ltda..
[125319626]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[125319627]
It was reported that bd spinal? Needle 26ga 3-1/2in broke during use. An incision and an? Image enhancer? Was used to remove a fragment of the broken needle. No further medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610048-2018-00174 |
| MDR Report Key | 8014914 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2018-10-29 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-09-21 |
| Date Mfgr Received | 2018-10-08 |
| Device Manufacturer Date | 2015-09-24 |
| Date Added to Maude | 2018-10-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. |
| Manufacturer Street | AVE. PRES.JUSCELINO KUBITSCHEK 273 FRANCISCO BERNARDINO |
| Manufacturer City | JUIZ DE FORA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD SPINAL ? NEEDLE 26GA 3-1/2IN |
| Generic Name | SPINAL NEEDLE |
| Product Code | MIA |
| Date Received | 2018-10-29 |
| Catalog Number | 408380 |
| Lot Number | 5240120 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. |
| Manufacturer Address | AVE. PRES.JUSCELINO KUBITSCHEK 273 FRANCISCO BERNARDINO JUIZ DE FORA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-29 |