InjuryFCH
ADULT LUMBAR PUNCTURE TRAY
Received Feb 9, 2017 · Event occurred Feb 8, 2017
Report MW5067829 · MDR key 6325466
Device
Product problems
- Leak/Splash
- Defective Device
Patient
100 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CATHETER PROVIDED WITH A LUMBAR PUNCTURE KIT LEAKS AND THE WHOLE BATCH IS BAD, MULTIPLE KITS LEAK. MULTIPLE LOT NUMBERS ARE DEFECTIVE. IS THE PRODUCT COMPOUNDED: NO. IS THE PRODUCT OVER-THE-COUNTER: NO. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.