MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for BD SPINAL NEEDLE QUINCKE TYPE POINT manufactured by Bd.
[176060626]
Pt needed a lumbar puncture (lp). The bd spinal needle that was going to be used for the lp has a hair stuck in the unopened package. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092372 |
| MDR Report Key | 9616088 |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-16 |
| Date of Event | 2020-01-16 |
| Date Added to Maude | 2020-01-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD SPINAL NEEDLE QUINCKE TYPE POINT |
| Generic Name | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
| Product Code | BSP |
| Date Received | 2020-01-21 |
| Lot Number | 9274342 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |