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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HALYARD STERLING NITRILE POWDER-FREE EXAM GLOVES NITRILE POWDER-FREE EXAM GLOVES - SIZE SMALL
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HALYARD STERLING NITRILE POWDER-FREE EXAM GLOVES NITRILE POWDER-FREE EXAM GLOVES - SIZE SMALL Back to Search Results
Catalog Number 50706
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2017
Event Type  malfunction  
Event Description
A medical laboratory technician, in the microbiology department, removed a glove directly from the box and proceeded to put it on her hand. When her hand was inside the glove, she felt something near the end of her fingertips on her ring and pinkie finger. She removed the glove and turned it inside out. A brown, crusty residue was noticed on the inside of the glove.
 
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Brand NameSTERLING NITRILE POWDER-FREE EXAM GLOVES
Type of DeviceNITRILE POWDER-FREE EXAM GLOVES - SIZE SMALL
Manufacturer (Section D)
HALYARD
5405 windward parkway
alpharetta GA 30004
MDR Report Key6553540
MDR Text Key74724518
Report Number6553540
Device Sequence Number1
Product Code LZC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/24/2017,05/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Catalogue Number50706
Device Lot NumberSM5282ZZZ_44BX
Other Device ID NumberDATE OF MANUFACTURE - 10/2015
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2017
Event Location Hospital
Date Report to Manufacturer02/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/09/2017 Patient Sequence Number: 1
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