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 |