MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for PORTEX NO EPINEPHRINE, SPINAL KIT NEPI-NLD-15583C-21 manufactured by Smiths Medical Asd, Inc..
[135695984]
Smith medical asd, inc. , portex no epinephrine spinal kit, nepi-nld-15583c-21 failed to work on patient. The bupivicaine spinal ampule in the kit, which is 0. 75% in dextrose 8. 25% did not produce an effect in the patient. The lot number and expiration date for the spinal kit used is lot# 362254 exp: 03/01/2020. The product was properly stored at controlled room temperature and was intact at time of usage. (b)(6), crna was whom used this kit on our campus. The patient was not complicated and did not have any anatomical issue that lead to spinal insertion complications. Due to complications from kit not working, the patient was forced to receive general anesthesia to finish c-section. Reason for use: cesarean section. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083651 |
| MDR Report Key | 8301212 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-24 |
| Date Added to Maude | 2019-02-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | PORTEX NO EPINEPHRINE, SPINAL KIT |
| Generic Name | NEEDLE SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-02-01 |
| Model Number | NEPI-NLD-15583C-21 |
| Lot Number | 364452 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Brand Name | PORTEX NO EPIMEPHRINE, SPINAL KIT |
| Generic Name | NEEDLE SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-02-01 |
| Model Number | NEPI-NLD15583C-21 |
| Lot Number | 3630577 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASD, INC |
| Brand Name | PORTEX NO EPINEPHRINE, SPINAL KIT |
| Generic Name | NEEDLE SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-02-01 |
| Model Number | NEPI-NLD-15583C-21 |
| Lot Number | 364452 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ASD, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-01 |