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

Model Number PG40LCKGK

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 11/05/2018

Event Type  malfunction  

Event 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
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1320 don haskins; suite a; el paso TX 79936
• MDR Report Key: 8084074
• MDR Text Key: 127590992
• Report Number: 8084074
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10887488975948
• UDI-Public: (01)10887488975948
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: PG40LCKGK
• Device Catalogue Number: PG40LCKGK
• Device Lot Number: #500785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1