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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.

DeviceSPINAL ANESTHESIA TRAY
Generic nameANESTHESIA CONDUCTION KIT
Report number10000518
Event typeMalfunction
Product problemY
Date received2020-04-27
Narrative0630: 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
SourceopenFDA MAUDE (device adverse events)

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