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

Model Number 8900SA

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

It was reported to covidien on (b)(4) 2014 that a customer received a needle stick.The customer reports the container contained needles that had been disposed of and one protruded through the plastic of the container and poked a supply clerk.The customer reported the needle punctured the container at approx the halfway mark of the container.The employee immediately washed the area with soapy water and then was sent to the urgent care center where they conducted blood tests and initiated treatment.

Manufacturer Narrative

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

Manufacturer Narrative

A review of the device history record data has been conducted on lot number 157783 which has shown no nonconforming events with the potential to lead to this complaint.A review of internal inspection rejections for this particular issue for finished good (b)(4) was performed and results showed no internal inspection rejections.Based on the photographs provided, review of this sample has shown: the needle was found penetrating the rear panel on the lower half of the container.The container fill level could not be determined.The force required to pass the penetrating needle through a similar container from the same lot meets all acceptance criteria.The wall thickness for a similar container from the same lot was within acceptable range.A review of changes to product, process, and packaging has been conducted identifying no affecting changes in the previous 12 months.With the information currently available, failure to follow documented instructions for use could cause the reported event.The root cause associated with this event has been identified as excessive force applied to the sharp, which caused penetration through the container wall.Based on the existing controls, examination and testing of the product, 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: 1 QT N/A CONTAINER RED 100
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): COVIDIEN; 815 tek dr.; crystal lake IL 60039
• 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: 4046933
• MDR Text Key: 4810785
• Report Number: 1424643-2014-00009
• 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,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2014
• 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?: No
• Date Manufacturer Received: 09/25/2014
• 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