MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC GEMCORNER; STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES

Catalog Number GEMCORNER

Device Problem Physical Property Issue (3008)

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

Event Date 02/24/2016

Event Type  malfunction  

Event Description

Upon opening case of protective foam corners, a large amount of flaky white debris noted.Unknown white debris was being occasionally found, post-sterilization, under trays inside sterile wrap in operating room.The surgical trays need to be removed from the room, and reprocessed when such unknown debris is found.This white flaky substance looks very similar.Staff has seen similar debris on the gemcorners once in a while, but this particular box had an excessive amount immediately upon opening the case.

• Brand Name: GEMCORNER
• Type of Device: STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline pl; mundelein IL 60060
• MDR Report Key: 5670967
• MDR Text Key: 45724459
• Report Number: 5670967
• Device Sequence Number: 1
• Product Code: FRG
• 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: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: GEMCORNER
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2016
• Device Age: 1 DY
• Event Location: Other
• Date Report to Manufacturer: 03/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1