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

Model Number Sterile Tray Liner System

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 307164100
• Report Number: 3012708860-2022-00001
• Device Sequence Number: 1
• Product Code: FFY
• UDI-Device Identifier: 18011517135801
• UDI-Public: 18011517135801
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/28/2022
• Initial Date FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1