MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH; LAPAROSCOPY KIT

Model Number	PG40LCKGK
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Cardinal health custom pack #pg40lckgk lot#500785 missing one tag sponge.Should be pack of 5.Sponges removed from room per policy.

• Brand Name: CARDINAL HEALTH
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1320 don haskins; suite a; el paso TX 79936
• MDR Report Key: 8084074
• Report Number: 8084074
• Device Sequence Number: 11178730
• Product Code: GCJ
• UDI-Device Identifier: 10887488975948
• UDI-Public: (01)10887488975948
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/08/2018
• Report Date (Section F): 11/08/2018

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: PG40LCKGK
• Device Catalogue Number: PG40LCKGK
• Device Lot Number: #500785
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/08/2018