inforMED
MalfunctionOTK

EXUFLOW FLAT FULL DUCT 10MM

Received Jan 24, 2022

Report 8030107-2021-00012 · MDR key 13331887

Device

Generic name

Exuflow Flat Full Duct 10mm

Model number

10MM

Catalog 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.