MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; DRAPE, SURGICAL

Model Number	MDT2168204
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A small bug was found in opened disposable blue towel on sterile field.The sterile set up was broken down before anything was used.The bug was photographed and the towel/packaging was saved.No harm came to the patient.The sterile field was reset and the procedure was completed as planned.Per site reporter: the medline rep was made aware and will alert their quality department.The towel will be handed over to the medline rep for return.

• Brand Name: MEDLINE
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7070381
• Report Number: 7070381
• Device Sequence Number: 19112374
• Product Code: KKX
• UDI-Device Identifier: 20080196834058
• UDI-Public: (01)20080196834058
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017
• Report Date (Section F): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: MDT2168204
• Device Catalogue Number: MDT2168204
• Device Lot Number: 84317060148
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/17/2017