MAUDE Adverse Event Report: DANIELS HEALTH SHARPSMART; SHARPS CONTAINER

Model Number S22

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/03/2016

Event Type  malfunction  

Event Description

Pt forcefully opened sharps container and retrieved syringes/needle.Sharps container was removed from pt room.

• Brand Name: SHARPSMART
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): DANIELS HEALTH; chicago IL 60604
• MDR Report Key: 5366144
• MDR Text Key: 36069061
• Report Number: MW5059305
• Device Sequence Number: 1
• Product Code: MMK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S22
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR