SPINAL ANESTHESIA TRAY Adverse Event — Malfunction (MDR 10000518)
SPINAL ANESTHESIA TRAY Adverse Event — Malfunction (MDR 10000518) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: SPINAL ANESTHESIA TRAY; Generic name: ANESTHESIA CONDUCTION KIT; Report number: 10000518.
| Device | SPINAL ANESTHESIA TRAY |
|---|---|
| Generic name | ANESTHESIA CONDUCTION KIT |
| Report number | 10000518 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | 0630: SCHEDULED REPEAT CESAREAN SECTION. EASY SPINAL, 1ST ATTEMPT BY CRNA. FREE FLOWING CEREBROSPINAL FLUID (CSF) DROPS AND SWIRL IN SYRINGE - 1.6ML OF KIT 0.75% BUPIVACAINE + 10MCG FENTANYL + 200MCG DURAMORPH INJECTED. FOLEY INSERTION NOT TOLERATED, PATIENT ABLE TO MOVE LEGS AND DIFFERENTIATE COLD, TOUCH, SHARP. LOT # OF SPINAL KIT - 0001311129. PATIENT HAD TO HAVE GENERAL ANESTHESIA DUE TO FAILE |
| Source | openFDA MAUDE (device adverse events) |
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