EXUFLOW FLAT FULL DUCT 10MM
Received Jan 24, 2022
Report 8030107-2021-00012 · MDR key 13331887
Device
Generic name
Exuflow Flat Full Duct 10mm
Manufacturer
Degania Silicone LtdModel number
10MMCatalog number
111039D1080MJ
Lot number
P2030817
Product problems
- Material Rupture
- Material Rupture
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
OUR IN-PROCESS CONTROL CONTAINS TENSILE STRENGTH TEST OF EVERY BATCH AND 100% VISUAL INSPECTION. NO SHARP OBJECTS ARE PRESENT ON THE WORKSTATIONS. THE TENSILE RESULTS OF THIS BATCH SHOWED IN-SPEC RESULTS. THE SKEWED AND INDENTED APPEARANCE OF THE TORN LINE IS TYPICAL FOR BREAKAGE DUE TO CUT OR NICK. BASED ON THE ABOVE, WE CONCLUDE THAT THE POSSIBILITY THE DRAIN TORE FOLLOWING ANY MANUFACTURING REASON IS REMOTE; DRAIN MOST PROBABLY WAS DAMAGED IN USE. ONE OF THE PROPERTIES OF SILICONE DRAINS IS TO SNAP EASILY IN PLACE OF SLIGHT CUT OR NICK. THE COMPLAINT CONSIDERED TO BE NOT JUSTIFIED; NO CAPA IS REQUIRED IN THIS CASE.
Description of Event or Problem
THE DRAIN TUBE BROKE AT AN ANGLE OF ABOUT 6 MM DURING USE.