MAUDE Adverse Event Report: COVIDIEN 1 QT N/S CONTAINER RED 100; SHARPS CONTAINER

Model Number 8900SA

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Other  

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue with a sharps container.The customer reports that when picking up the sharps container an employee was stuck with a dirty needle stick.The customer further reports that the container was picked up and placed in the inside of the arm (like carrying something), and the needle punctured through the side of the container and the employee was struck on the inside of the forearm.The employee is going through their facilities protocol and they have also had blood drawn up from the patient.

Manufacturer Narrative

Submit date: (b)(4) 2014.An investigation is currently underway.Upon completion, the results will be forwarded.

• Brand Name: 1 QT N/S CONTAINER RED 100
• 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: janice nevius ; 15 hampshire st.; mansfield, MA 02048 ; 5082616283
• MDR Report Key: 3913920
• MDR Text Key: 16800365
• Report Number: 1424643-2014-00007
• 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: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8900SA
• Device Catalogue Number: 8900SA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other