MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-19 for ARROW SPINAL TRAY manufactured by Arrow.
[36914018]
Spinal anesthesia was attempted using hospira bupivacaine from an arrow spinal tray lot # 23f15j0936. The bupivacaine lot was 54438ev. The patient did not respond to the spinal anesthesia and underwent the procedure under general anesthesia. Reason for use: spinal anesthesia for a total vaginal hysterectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059556 |
| MDR Report Key | 5384793 |
| Date Received | 2016-01-19 |
| Date of Report | 2016-01-19 |
| Date of Event | 2015-12-29 |
| Date Added to Maude | 2016-01-22 |
| 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 | PHARMACIST |
| 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 | ARROW SPINAL TRAY |
| Generic Name | SPINAL TRAY |
| Product Code | OFT |
| Date Received | 2016-01-19 |
| Lot Number | 23F1550936 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARROW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-19 |