MalfunctionFMC
QUEEN DISPOSABLE NITRILE GLOVES
Received Apr 2, 2021 · Event occurred Mar 31, 2021
Report MW5100542 · MDR key 11613180
Device
Generic name
Patient Examination Glove
Manufacturer
Guangdong Junan Medical Technology Co.,ltdModel number
DISPOSABLE NITRILE GLOVESLot number
NONE AVAILABLE;PRESUMED MULTIP
Product problems
- Material Puncture/Hole
- Product Quality Problem
- Material Split, Cut or Torn
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
I AM A BEDSIDE NURSE IN THE ICU. MY HOSPITAL HAS BEEN USING QUEEN DISPOSABLE NITRILE GLOVES FOR EXAM GLOVES FOR A FEW MONTHS. THESE ARE DANGEROUSLY POOR QUALITY, WITH FREQUENT HOLES, ESPECIALLY IN THE FINGERS AND OFTEN TEAR WITHOUT ANY OBVIOUS PROVOCATION. I HAVE REPORTED THIS TO MY EMPLOYER, BUT I BELIEVE THAT THE FDA SHOULD ALSO ADDRESS THIS ISSUE. FDA SAFETY REPORT ID # (B)(4).