MalfunctionOTK
ROUND SILICONE DRAIN 7FR
Received Jan 24, 2021
Report 8030107-2021-00001 · MDR key 11220564
Device
Generic name
Round Silicone Drain 7fr
Manufacturer
Degania Silicone LtdModel number
7 FRCatalog number
DYNJWE1320
Lot number
UNK
Product problems
- Material Rupture
- Material Rupture
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DRAIN MOST LIKELY WAS DAMAGED IN USE. NO CAPA WILL BE INITIATED FOLLOWING THIS EVENT.
Description of Event or Problem
DRAIN BROKEN/CRACKED/FRACTURED DURING USE. THERE WAS A BREAK OF ABOUT 1 MM IN THE TUBE.