MAUDE Adverse Event Report: COVIDIEN 5 QT INRM W/LID CLEAR 20; SHARPS CONTAINER

Model Number 85121

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/13/2014

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 a syringe poked through the container and scratched an employee.

Manufacturer Narrative

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

• Brand Name: 5 QT INRM W/LID CLEAR 20
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9
• Manufacturer (Section G): COVIDIEN; 815 tek dr.; crystal lake IL 6003
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3844674
• MDR Text Key: 4679742
• Report Number: 1424643-2014-00003
• 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: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 85121
• Device Catalogue Number: 85121
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/15/2014
• Date Manufacturer Received: 05/14/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other