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

Model Number SBA12LC76F

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Insufficient Information (4580)

Event Date 04/15/2021

Event Type  malfunction  

Event Description

A hair was found in a cardinal health lap cholecystectomy pack during the pre-operative setup for a case.The entire field had to be redone due to contamination, causing delay of case and waste of 3 trays and disposable supplies.

• 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: 11768807
• MDR Text Key: 248794889
• Report Number: 11768807
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SBA12LC76F
• Device Catalogue Number: SBA12LC76F
• Device Lot Number: 583235
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1