MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. 7496 HFS MINI PLUS KIT; GENERAL SURGERY TRAY

Model Number	DYNJ10210B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The 7496 hfs mini plus kit by medline contained 4 lap sponges instead of 5.

• Brand Name: 7496 HFS MINI PLUS KIT
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 9590502
• Report Number: 9590502
• Device Sequence Number: 3080391
• Product Code: LRO
• UDI-Device Identifier: 10889942126491
• UDI-Public: (01)10889942126491
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/08/2020
• Report Date (Section F): 01/08/2020

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 Model Number: DYNJ10210B
• Device Catalogue Number: DYNJ10210B
• Device Lot Number: 19GBI050
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2020
• 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: 01/08/2020