MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. LAP CHOLE PACK; LAPAROSCOPY KIT

Model Number	DYNJ0395986K
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A custom medline surgical pack was received with a note stating "the outer dust cover had a tear in it and there was also a tear on the blue drape cover-exactly in the same spot as the outer dust cover hole." the holes had been circled by surgical staff, and were photographed.This was discovered prior to the start of a case, and no harm came to the patient.The field rep has been made aware and will pick up the pack to pass along to medline's quality team.

• Brand Name: LAP CHOLE PACK
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 3 lakes dr; northfield IL 60093
• MDR Report Key: 7319978
• Report Number: 7319978
• Device Sequence Number: 13480303
• Product Code: FDE
• UDI-Device Identifier: 10889942163298
• UDI-Public: (01)10889942163298
• 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): 03/02/2018
• Report Date (Section F): 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 03/31/2022
• Device Model Number: DYNJ0395986K
• Device Catalogue Number: DYNJ0395986K
• Device Lot Number: 17ID3137
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2018
• 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: 03/02/2018