BUSSE HOSPITAL DISPOSABLES
Received Nov 17, 2023 · Event occurred May 23, 2023
Report 18159020 · MDR key 18159020
Device
Patient
28835 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
FEEDBACK PROVIDED BY PROVIDER. PROVIDER EXPRESSED CONCERN THAT THE NEEDLE QUALITY HAS DECLINED SIGNIFICANTLY. INCIDENT IN WHICH THE NEEDLE CURVED IN AN ARC JUST AFTER PUNCTURING SKIN. PROVIDER FEELS THE SPINAL NEEDLES HAVE A MUCH LARGER STYLET BASE THAT DOES NOT ¿CLICK IN¿ PROPERLY. PROVIDER HAS ALSO EXPRESSED CONCERN THAT THE FOAM STOP IS IN THE KIT, IT IS JUST A BLOCK THAT IS NOT ADHERED TO ANYTHING; THEREFORE THE NEEDLE CAN COME OUT OF THE BACK OR FALL OVER. REMOVING THE BLOCK FROM THE TIP OF THE NEEDLE IS AN EXPOSURE RISK. PROVIDER ALSO EXPRESSED CONCERN THAT THE DRAPE IS THE SAME SIZE, BUT THE FENESTRATION IS MUCH SMALLER. IT DOES NOT OVERLAP MULTIPLE SPINAL LEVELS SO IF WE NEED TO CHANGE SPINAL LEVELS (FAIRLY COMMON) THE DRAPE NEEDS TO BE REMOVED, WHICH COMPROMISES THE STERILITY OF THE PROCEDURE.