MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for VINE L-0130-KERRISON, NEURO/SPINE manufactured by Bd/carefusion.
[140309112]
Front portion of v. Mueller, neuro/spine, vine, l-0130, 2mm kerrison, broke off into the patient's brain tissue while in use. The broken portion of the instrument was retrieved, and the instrument was removed from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085275 |
| MDR Report Key | 8460121 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-03-22 |
| Date Added to Maude | 2019-03-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VINE L-0130-KERRISON, NEURO/SPINE |
| Generic Name | INSTRUMENT, SURGICAL, NON-POWERED |
| Product Code | HAO |
| Date Received | 2019-03-27 |
| Model Number | VINE L-0130 |
| Catalog Number | VINE L-0130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BD/CAREFUSION |
| Brand Name | VINE L-0130-KERRISON, NEURO/SPINE |
| Generic Name | INSTRUMENT, SURGICAL, NON-POWERED |
| Product Code | HAO |
| Date Received | 2019-03-27 |
| Model Number | VINE L-0130 |
| Catalog Number | VINE L-0130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | V. MUELLER/ BDI CAREFUSION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-27 |