MAUDE Adverse Event Report: COVIDIEN 5QT.CNT.W/CONTR BLNC DR RED20; SHARPS CONTAINER

Model Number 8507SA

Device Problems Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/29/2014

Event Type  Other  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue with a sharps container.The customer reports the sharps containers had been collected from the floor sand had been sent down to be autoclaved then disposed of as per the hospital protocol.The container was autoclaved then the worker was moving it to another area fro disposal when the needle stick occurred due to a sharps sticking out of the middle bottom part of the container.The container had been autoclaved so the employee did not go through the same medical testing as normal needle stick injury would call for, but did receive a tetanus shot.Because the customer did seek additional medical attention by means of a tetanus shot, an mdr has been filed.The purpose of the autoclave is to destroy the bio-hazardous substances in the container.As such, needles poking through the container after the extreme heat of the autoclave process are not a malfunction of the device, and do not present a risk of a contaminated needle-stick.

Manufacturer Narrative

An investigation is currently underway, upon completion the results will be forwarded.

• Brand Name: 5QT.CNT.W/CONTR BLNC DR RED20
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): COVIDIEN; 815 tek dr.; crystal lake IL 60039 900
• Manufacturer (Section G): COVIDIEN; 815 tek dr.; crystal lake IL 60039 900
• Manufacturer Contact: elaine bishop ; 15 hampshire st.; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3843796
• MDR Text Key: 4662816
• Report Number: 1424643-2014-00004
• 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
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8507SA
• Device Catalogue Number: 8507SA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other