MAUDE Adverse Event Report: DYNAREX CORPORATION DYNAREX SHARPS CONTAINER; CONTAINER, SHARPS

Model Number 4624

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/14/2016

Event Type  malfunction  

Event Description

A nurse was stuck with a needle protruding through a sharps container.

• Brand Name: DYNAREX SHARPS CONTAINER
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): DYNAREX CORPORATION; 10 glenshaw street; orangeburg NY 10962 1207
• MDR Report Key: 5746357
• MDR Text Key: 48095553
• Report Number: 2431014-2016-00001
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4624
• Device Catalogue Number: 4624
• Device Lot Number: 31084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other