inforMED
MalfunctionLHC

ORS-100N WARMER DRAPE

Received Mar 13, 2018

Report 8043817-2018-00007 · MDR key 7335774

Device

Generic name

Fluid Warming And Slush Drapes

Model number

ORS-100N

Lot number

D161731

Product problems

  • Hole In Material
  • Hole In Material

Patient

Not reported

  • No Patient Involvement
  • No Patient Involvement

Narrative

Additional Manufacturer Narrative

THE SAMPLE RECEIVED WAS EVALUATED. A SMALL CUT/HOLE WAS OBSERVED ABOUT 5 1/2 INCHES FROM THE CENTER OF THE DRAPE. THIS LOOKS TO HAVE BEEN CAUSED BY A SHARP OF SOME SORT. THE DHR WAS REVIEWED AND IT WAS NOTICED THAT THIS LOT HAD 95 CASES THAT WERE MANUFACTURED FROM 06/21/2016 TO 06/22/2016. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. THIS IS A NON STERILE PART THAT IS SUPPLIED TO A KIT PACKER FOR FURTHER PACKAGING AND STERILIZATION. BASED ON THE DEVICE HISTORY RECORD AND SAMPLE REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. BECAUSE THIS APPEARS TO BE RELATED TO MISUSE BY THE CUSTOMER, NO ACTIONS ARE BEING TAKEN AT THIS TIME.

Description of Event or Problem

A CUSTOMER IS REPORTING A COMPLAINT FROM A HOSPITAL STATING THAT THEY RECEIVED A FLUID WARMER DRAPE THAT CONTAINED A HOLE WITHIN THE DRAPE. THE SAMPLE WAS RECEIVED BY THE CUSTOMER AND THE REPORTED CONCERN WAS CONFIRMED. A SMALL TEAR WITHIN THE PLASTIC WAS NOTED AND UPON EXAMINING THE LOCATION OF THE DRAPE, IT WAS NOTED THAT THERE WAS NOTHING SHARP NEXT TO THE DRAPE THAT COULD HAVE CAUSED SUCH A TEAR. ALSO, THE DRAPE IS RECEIVED FOLDED AND IS PLACED WITHIN THE KIT AS SUCH.