MAUDE Adverse Event Report: COVIDIEN 2 GA N/S COLLECTION CONT RED20; SHARPS CONTAINER

Model Number 8970

Device Problem Material Puncture/Hole (1504)

Patient Problems Laceration(s) (1946); Needle Stick/Puncture (2462)

Event Type  Injury  

Manufacturer Narrative

Submit date: 12/30/2015.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a sharps container.The customer reports she went to grab the sharps container when a needle punctured through the sharps container and sliced her left index finger even though she was wearing latex gloves.The container was not autoclaved was filled to the fill line.A 16 gage needle sticking out of container.The container was being put in big sharps bin for pickup.The container did not fall and no blunt force was applied to the container.The person who got stuck had hiv and hep panel blood work done.

• Brand Name: 2 GA N/S COLLECTION CONT RED20
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5336264
• MDR Text Key: 34736059
• Report Number: 1424643-2015-00008
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8970
• Device Catalogue Number: 8970
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/09/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other