MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; GENERAL SURGERY TRAY

Model Number	PHS397101008
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Operating room (or) opened for laparoscopic preperitoneal bilateral inguinal hernia repairs with a minor abdominal pack.The surgical team opened for the procedure, when the sa noted a long, black hair within the laparotomy sponge.A picture was taken, the room was torn down, and the pack was given to the charge lead nurse.Quality and safety, as well as the manufacturer representative, were made aware.A new pack was set up and the procedure was completed as planned with no harm to the patient.Per site reporter: the manufacturer representative was notified and picked up the contaminated pack.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1160 s. northpoint blvd.; waukegan IL 60085
• MDR Report Key: 6992771
• Report Number: 6992771
• Device Sequence Number: 1293036
• Product Code: LRP
• UDI-Device Identifier: 10889942037810
• UDI-Public: (01)10889942037810
• 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): 10/31/2017
• Report Date (Section F): 10/31/2017

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: PHS397101008
• Device Catalogue Number: PHS397101008
• Device Lot Number: 17HD2883
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/31/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 63
• Date Report Sent to FDA: 10/31/2017