MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for SMITHS MEDICAL PORTEX NO EPI SPINAL KIT NEPI-NLD15583C-21 manufactured by Smiths Medical Asd, Inc.
[135888033]
Smiths medical asd, inc portex no epinephrine spinal kit, nepi-nld-15583c-21 failed to work on multiple patients. 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 kits used is unfortunately were different but include lot numbers #3644572, exp: 03/01/2020. Lot#3702072, exp 06/01/2020 and lot #3630577, exp 03/01/2020. The product was properly stored at controlled room temperature and was intact at time of usage. Multiple anesthesiologists used the product which sometimes worked and sometimes did not, and unfortunately it wasn? T just one lot # that was affected. The kits themselves appear to work but the bupivacaine in them is not effective. What we are not doing is using the kits but not using the supplies bupivacaine spinal, rather bupivacaine supplied by the pharmacy department. The patients were not complicated patients and did not have any anatomical issues that lead to spinal insertion complications. Due to complications from kits not working, the patients were forced to receive general anesthesia to finish procedure. We have 20 unopened kits we would love for the fda to evaluate. Dates of use: (b)(6) 2018? (b)(6) 2019. Event abated after use: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5083652 |
| MDR Report Key | 8301232 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-29 |
| 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 | 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 | SMITHS MEDICAL PORTEX NO EPI SPINAL KIT |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-02-01 |
| Model Number | NEPI-NLD15583C-21 |
| Lot Number | 3644572 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC |
| Brand Name | SMITHS MEDICAL PORTEX NO EPI SPINAL KIT |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-02-01 |
| Model Number | NEPI-NLD-15583C-21 |
| Lot Number | 3702072 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC |
| Brand Name | SMITHS MEDICAL PORTEX NO EPI SPINAL KIT |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-02-01 |
| Model Number | NEPI-NLD-15583C-21 |
| Lot Number | 3630577 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |