MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. SURGICAL KIT (HEMM 221238 SHEET THREE QUARTER REINFORCED 53X77); GENERAL SURGERY TRAY

Model Number DYNJP2416

Device Problem Device Contamination With Biological Material (2908)

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

Event Date 12/28/2017

Event Type  malfunction  

Event Description

Operating room (or) staff began setting up for surgical procedure.As the scrub person opened a 3/4 sheet drape (part of the vascular bypass tote), staff discovered a large beetle, a fly, and hair on the inside of the drape upon opening.Drape was removed from operating room.The staff in the room broke down their set up and opened a new tote.Patient was not affected as patient was not yet in operating room.

• Brand Name: SURGICAL KIT (HEMM 221238 SHEET THREE QUARTER REINFORCED 53X77)
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; 1204 townline rd; mundelein IL 60060
• MDR Report Key: 7211764
• MDR Text Key: 97969541
• Report Number: 7211764
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJP2416
• Device Catalogue Number: DYNJP2416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2018
• 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