MAUDE Adverse Event Report: CANTEL ITALY S.R.L. CLEANASCOPE LINERS

Model Number	Sterile Tray Liner System
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
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.

• Brand Name: CLEANASCOPE LINERS
• Common Device Name: LINERS
• Manufacturer (Section D): CANTEL ITALY S.R.L.; via laurentina, 169; pomezia, roma 00071 ; IT 00071
• Manufacturer (Section G): CANTEL ITALY S.R.L.; via laurentina, 169; pomezia, roma 00071 ; IT 00071
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 15780843
• Report Number: 3012708860-2022-00001
• Device Sequence Number: 4674935
• Product Code: FFY
• UDI-Device Identifier: 18011517135801
• UDI-Public: 18011517135801
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: Sterile Tray Liner System
• Device Catalogue Number: 103580
• Device Lot Number: 2106032808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown