MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-27 for PORTEX SPINAL 25 G WHITACRE (NO EPINEPHRINE) NEPI-NLD 15597C-20 manufactured by Smiths Medical.
[112844275]
Above patient was scheduled to undergo a cesarean section. Prior to spinal injection for spinal block, a particulate, which appeared to be plastic, was noted in the barrel of the syringe. The syringe was not used on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078114 |
| MDR Report Key | 7645559 |
| Date Received | 2018-06-27 |
| Date of Report | 2018-06-25 |
| Date of Event | 2018-06-21 |
| Date Added to Maude | 2018-06-28 |
| 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 |
| 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 | PORTEX SPINAL 25 G WHITACRE (NO EPINEPHRINE) |
| Generic Name | PORTEX SPINAL 25 G WHITACRE (NO EPINEPHRINE) |
| Product Code | MIA |
| Date Received | 2018-06-27 |
| Model Number | NEPI-NLD 15597C-20 |
| Lot Number | 3637355 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL |
| Manufacturer Address | KEENE NH 03431 US 03431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-27 |