inforMED
MalfunctionIQE

ADULT LUMBAR PUNCTURE TRAY 20X3 1/2

Received Oct 4, 2001 · Event occurred Sep 5, 2001

Report 1423507-2001-00236 · MDR key 354745

Device

Generic name

Procedure Tray

Model number

4301C

Catalog number

4301C

Lot number

L1J007

Product problems

  • Fluid/Blood Leak
  • Unable to Obtain Readings
  • Defective Device

Patient

UNKNOWN

  • Headache, Lumbar Puncture
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

DR STATES THAT CIRCUMSTANCES OF MANOMETER IS NOT RIGHT WHICH IS CAUSING A NON MEASUREMENT OF PRESSURE AND CAUSED LEAKAGE OF FLUID WHICH CAUSED PT TO EXPERIENCE POST HEADACHE SYMPTOMS CAUSING PT STAY TO EXCEED APPROXIMATELY 3HRS THEN GOING TO ER. SPOKE WITH RN WHO CONFIRMED ABOVE STATEMENT. SHE WAS NOT SURE WHAT TYPE OF ADDITIONAL MEDICATION OR INTERVENTION, OTHER THAN OBSERVATION, WAS REQUIRED AS A RESULT OF THE INCIDENT.