MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; GENERAL SURGERY TRAY

Model Number	SBA56GPIHM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
While draping the patient, the scrub tech discovered a hole in the lap cholecystectomy drape that was provided in the gen pack ucr #sbagpihm lot#334264 exp.2024-03-01.There was no incision made on the patient at this time and we discarded all supplies on the back table and mayo stand without using any supplies on the patient.The hole appeared to be a manufacturer defect of the drape and not a hole that would have been punctured by an object.The drape was saved for risk management along with the pack contents sheet with the lot #, etc on it.

• Brand Name: CARDINAL HEALTH
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 9752990
• Report Number: 9752990
• Device Sequence Number: 11493266
• Product Code: LRO
• UDI-Device Identifier: 10887488722580
• UDI-Public: (01)10887488722580
• 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): 01/17/2020
• Report Date (Section F): 01/17/2020

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: Other
• Device Model Number: SBA56GPIHM
• Device Catalogue Number: SBA56GPIHM
• Device Lot Number: 334264
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 130
• Date Report Sent to FDA: 01/17/2020