MAUDE Adverse Event Report: COVIDIEN 8 GAL NEEDLE DISP CONTAINER 10; SHARPS CONTAINER

Model Number 8980

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/15/2014

Event Type  Injury  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer had an issue which occurred with a sharps container.The customer reports that after the sharps container had been autoclaved and was being moved for final disposal a needle stuck through the middle part of the container and the floor tech was stuck with a needle that was poking through.The staff member that was stuck with the needle underwent the hospital's needle stick exposure testing as a result of this incident.No further medical intervention has been done at this time.

Manufacturer Narrative

(b)(4).An investigation is currently underway, upon completion, the results will be forwarded.

Manufacturer Narrative

A review of the device history record for this product could not be conducted since a lot number could not be provided.A review of internal inspection rejections for this particular issue for finished good (b)(4) was performed and results showed no internal inspection rejections.There have been no samples and no photographs provided for review.A review of changes to product, process, and packaging has been conducted identifying no affecting changes in the previous 12 months.A potential root cause associated with this event has been identified as handling of the sharps container after autoclaving without the use of adequate protective equipment.Based on the existing controls, examination and review of similar production samples, the internal rejection and the complaint history review, additional correction or containment activities are not warranted at this time.Based on the information available and the investigation findings, a corrective and preventive action (capa) is not deemed necessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 8 GAL NEEDLE DISP CONTAINER 10
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): COVIDIEN; 815 tek dr.; crystal lake IL 60039 900
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60039 900
• Manufacturer Contact: elaine bishop ; 15 hampshire street; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 4115763
• MDR Text Key: 4837078
• Report Number: 1424643-2014-00010
• 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,Followup
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8980
• Device Catalogue Number: 8980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other