MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS NEPI-NLD-15597C-20 manufactured by Smiths Medical Asd, Inc..
[105398749]
Patient Sequence No: 1, Text Type: N, H10
[105398750]
Four reports of inadequate spinal anesthesia using the smith spinal tray. Patients had diminished sensation and motor weakness, but could still feel and move their legs. General anesthesia required to proceed with surgical procedure. We have recently reported another manufacturer spinal trays as well, the medication in both trays is supplied by the same drug manufacturer. It is the same medication concentration, but they do have different numbers on them. We have only been using this tray for approximately 1 month and we have seen about 10 confirmed cases of inadequate spinals that have had to be converted to general anesthesia. All of the patients had some motor weakness and some sensory deficit, but not enough to perform surgery on them. Manufacturer response for smith spinal tray, (brand not provided) (per site reporter): no response at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7428316 |
| MDR Report Key | 7428316 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-04-05 |
| Report Date | 2018-04-10 |
| Date Reported to FDA | 2018-04-10 |
| Date Reported to Mfgr | 2018-04-10 |
| Date Added to Maude | 2018-04-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | PORTEX PENCIL POINT SPINAL ANESTHESIA TRAYS |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2018-04-13 |
| Catalog Number | NEPI-NLD-15597C-20 |
| Lot Number | 3566332 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 US 03431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |