MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-03-17 for PENCAN SPINAL NEEDLE TRAY * manufactured by B Braun Medical Inc..
[18892841]
Female g1 pre-operation for a c-section for 38+ 5 weeks estimated gestational age (ega) w/arrest of dilation and descent/primary low transverse cesearean section. Anesthesoologist placed spinal needle and injected medications, patient was placed in supine position but spinal did not "set up". After 15 minutes, doctor repeated spinal using bupivacaine from anesthesia cart instead of spinal tray and patient got pain relief in 2 minutes. C-section completed with no additional complications and patient to pacu post-procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4622616 |
| MDR Report Key | 4622616 |
| Date Received | 2015-03-17 |
| Date of Report | 2015-03-17 |
| Date of Event | 2015-03-16 |
| Report Date | 2015-03-17 |
| Date Reported to FDA | 2015-03-17 |
| Date Reported to Mfgr | 2015-03-23 |
| Date Added to Maude | 2015-03-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN SPINAL NEEDLE TRAY |
| Generic Name | ANESTHESIA CONDUCTION KIT |
| Product Code | HAS |
| Date Received | 2015-03-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 61411055 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B BRAUN MEDICAL INC. |
| Manufacturer Address | 824 TWELFTH AVENUE BETHEHEM PA 18018 US 18018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-17 |