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

Model Number PG40LCKGM01

Device Problem Packaging Problem (3007)

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

Event Date 04/30/2022

Event Type  malfunction  

Event Description

Or reports that a cardinal health custom lap chole pack contained x6 tags when it should have only had x5.

• Brand Name: CARDINAL HEALTH
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 14873708
• MDR Text Key: 295054695
• Report Number: 14873708
• Device Sequence Number: 1
• Product Code: FDE
• 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: 06/22/2022,05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PG40LCKGM01
• Device Catalogue Number: PG40LCKGM01
• Device Lot Number: 804793
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1