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

Model Number	DYNJCD0231
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The scrub tech was wearing a level 4 surgical gown and was standing with her upper thigh against the lateral edge of the patient's incision.The blood from the surgical site soaked through the gown and into her surgical scrubs, then onto her skin.There was significant strike through.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 14976515
• Report Number: 14976515
• Device Sequence Number: 12220336
• Product Code: FSM
• UDI-Device Identifier: 10889942163267
• UDI-Public: 10889942163267
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2022
• Report Date (Section F): 04/15/2022

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
• Device Model Number: DYNJCD0231
• Device Catalogue Number: DYNJCD0231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/15/2022