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

Model Number SUT21MBARD

Device Problem Separation Failure (2547)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2016

Event Type  malfunction  

Event Description

The mayo stand covers in the major basin packs are fused together.We are pulling individual mayo stand covers from the shelf and discarding the ones that are fused together to have product to use for surgical cases.The operating room clinical supervisor has spoken with the cardinal rep, (b)(4), and she was made aware of our issue with the mayo stand covers.Manufacturer response for mayo stand cover, mayo stand cover (per site reporter): rep notified.

• Brand Name: CARDINAL HEALTH
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 6215599
• MDR Text Key: 63641068
• Report Number: 6215599
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SUT21MBARD
• Device Catalogue Number: SUT21MBARD
• Other Device ID Number: 604634
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO