MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CONVERTORS; DRAPE, SURGICAL, EXEMPT

Model Number	9349
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While opening to the back surgical table, scrub tech noticed that the outside packaging, of the convertors general purpose sterile three-quarter drape, was stuck to the inside sterile wrapping.As it was opened, it ripped the inside wrapping making it no longer sterile.

• Brand Name: CONVERTORS
• Common Device Name: DRAPE, SURGICAL, EXEMPT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11841001
• Report Number: 11841001
• Device Sequence Number: 3660984
• Product Code: PUI
• UDI-Device Identifier: 10885380062261
• UDI-Public: (01)10885380062261
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2021
• Report Date (Section F): 05/06/2021

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: No Information
• Device Model Number: 9349
• Device Catalogue Number: 9349
• Device Lot Number: 20LEC124
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 64
• Date Report Sent to FDA: 05/06/2021