MAUDE Adverse Event Report: DANIELS SHARPSMART SHARPSMART; SHARPS CONTAINER

Model Number S22 REGULAR

Device Problem Fail-Safe Design Failure (1222)

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

Event Date 11/26/2014

Event Type  Injury  

Event Description

Pt removed sharps container from wall, took it into bathroom and was able to remove needles, syringes and medication vials without breaking the safety tray.Items were taken from pt before any harm could be done.

• Brand Name: SHARPSMART
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): DANIELS SHARPSMART; chicago IL 60604
• MDR Report Key: 4417636
• MDR Text Key: 5413246
• Report Number: MW5040204
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: S22 REGULAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Weight: 88