MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE STERILIE BASIC SURGICAL SET-UP TRAY; GENERAL SURGERY TRAY, LIGHT HANDLE COVER

Catalog Number DYNJS0105

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/18/2016

Event Type  malfunction  

Event Description

Large hole in the green light handle cover.Had to open another set of light covers.

• Brand Name: MEDLINE STERILIE BASIC SURGICAL SET-UP TRAY
• Type of Device: GENERAL SURGERY TRAY, LIGHT HANDLE COVER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 5982901
• MDR Text Key: 55800812
• Report Number: 5982901
• 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: Patient
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DYNJS0105
• Device Lot Number: 16GB9601
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1