MAUDE Adverse Event Report: HALYARD STERLING NITRILE POWDER-FREE EXAM GLOVES; NITRILE POWDER-FREE EXAM GLOVES - SIZE SMALL

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.

• Brand Name: STERLING NITRILE POWDER-FREE EXAM GLOVES
• Type of Device: NITRILE POWDER-FREE EXAM GLOVES - SIZE SMALL
• Manufacturer (Section D): HALYARD; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 6553540
• MDR Text Key: 74724518
• Report Number: 6553540
• Device Sequence Number: 1
• Product Code: LZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• 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 Received: 05/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 50706
• Device Lot Number: SM5282ZZZ_44BX
• Other Device ID Number: DATE OF MANUFACTURE - 10/2015
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other