MAUDE Adverse Event Report: HALYARD HEALTH, INC. FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR AND DUCKBILL SURGICAL MASK; MASK, SURGICAL

Model Number	46767
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
We are having an issue with the duckbill mask 46767 from kimberly-clark.The lot number in question am9258b81.The elastic doesn't retract, just stretches and sometimes breaks.It looks like some of these masks could have dry rot.This was identified prior to use.

• Brand Name: FLUIDSHIELD N95 PARTICULATE FILTER RESPIRATOR AND DUCKBILL SURGICAL MASK
• Common Device Name: MASK, SURGICAL
• Manufacturer (Section D): HALYARD HEALTH, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7822178
• Report Number: 7822178
• Device Sequence Number: 16407266
• Product Code: FXX
• UDI-Device Identifier: 20680651467670
• UDI-Public: (01)20680651467670
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/15/2018
• Report Date (Section F): 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 46767
• Device Catalogue Number: 46767
• Device Lot Number: AM9258B81
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2018
• 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: 08/15/2018