MAUDE Adverse Event Report: COVIDIEN 5QT TAMPER PROOF TRANS. RED 20; SHARPS CONTAINER

Model Number 8509SA

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/19/2014

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 states the nurse was stuck by a 8mm insulin pen needle that went through the lid of the container while the nurse was closing it.The nurse went for blood work following the incident, results are still unknown.

Manufacturer Narrative

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

• Brand Name: 5QT TAMPER PROOF TRANS. RED 20
• 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 street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3878043
• MDR Text Key: 20787949
• Report Number: 1424643-2014-00006
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8509SA
• Device Catalogue Number: 8509SA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2014
• Initial Date FDA Received: 06/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other