MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for PENCAN SPINAL NEEDLE TRAY 333851 manufactured by B. Braun / B. Braun Melsungen Ag.
[185223674]
Pencan spinal needle tray lot failed. Medication administered via spinal did not numb. Lot pulled from circulation. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093933 |
| MDR Report Key | 9883157 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-11 |
| Date Added to Maude | 2020-03-26 |
| 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 | RISK MANAGER |
| 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 | PENCAN SPINAL NEEDLE TRAY |
| Generic Name | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
| Product Code | BSP |
| Date Received | 2020-03-25 |
| Model Number | 333851 |
| Lot Number | 0061715526 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN / B. BRAUN MELSUNGEN AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |