MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH LLC SHARPSAFETY SHARPS CONTAINTER; CONTAINER, SHARPS

Model Number 8303SA

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

Sharps container used in the ems setting allowed for a needle to pierce the side of the container, causing an unprotected exposure/needle stick.Fda safety report id# (b)(4).

• Brand Name: SHARPSAFETY SHARPS CONTAINTER
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH LLC
• MDR Report Key: 11685027
• MDR Text Key: 246262731
• Report Number: MW5100837
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8303SA
• Device Catalogue Number: 8303SA
• Device Lot Number: 20C11863
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 80