CLEANASCOPE LINERS
Received Nov 11, 2022 · Event occurred Oct 13, 2022
Report 3012708860-2022-00001 · MDR key 15780843
Device
Generic name
Liners
Manufacturer
Cantel Italy S.r.l.Model number
Sterile Tray Liner SystemCatalog number
103580
Lot number
2106032808
Product problems
- No Apparent Adverse Event
- No Apparent Adverse Event
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A STERIS SALES REPRESENTATIVES DISCUSSED THE REPORTED EVENT WITH USER FACILITY PERSONNEL WHO STATED THAT SEVERAL CLEANASCOPE LINERS FROM THE LOT SUBJECT OF THE REPORTED EVENT WERE TEARING ALONG THE CENTRAL FOLD PRIOR TO INSTALLMENT IN THE BOTTOM OF THE TRAY. THE REMAINING CLEANASCOPE LINERS FROM THE LOT ASSOCIATED WITH THIS COMPLAINT AT THE USER FACILITY WERE DISPOSED OF. AS THE CLEANASCOPE LINERS WERE DISPOSED OF, STERIS IS UNABLE TO INSPECT AND EVALUATE THE LINERS SUBJECT OF THE REPORTED EVENT; A ROOT CAUSE CANNOT BE DETERMINED. THE USER FACILITY RECEIVED REPLACEMENT PRODUCT AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED THAT THE WHITE LINER TEARS, ALONG THE CENTRAL FOLD, WHEN IT IS UNFOLDED PRIOR TO BEING INSTALLED IN THE BOTTOM OF THE TRAY. NO REPORT OF INJURY.