MAUDE Adverse Event Report: COVIDIEN SAG14-827-122 FISHER 5QT RED; SHARPS CONTAINER

Model Number 31323176

Device Problem Insufficient Information (3190)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

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) has been performed and results showed no internal inspection rejections.A representative sample was not received for evaluation.Based on investigation responses and like production samples, the following have been verified: the sharps container was filled near or slightly above the recommended fill level, the container fell over, and the needle did not penetrate the container.The sharps containers of the same product code have demonstrated adequate design and manufacture to exceed all puncture resistance standards.Photographs provided show a similar, unused container, however no additional information can be obtained from these photographs.A review of changes to product, process, and packaging has been conducted identifying no affecting changes in the previous 12 months.The root cause associated with this event has been identified as excessive jostling of the sharps container through dropping.Based on the existing controls, examination and testing of 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.

Event Description

It was reported to covidien on (b)(6) 2014 that a customer had an issue involving a sharps container.The customer reports a needle stick injury occurred with the a-gator 5 quart red container.The customer states that on the top of the lid there is a hinge mechanism, which is there to block sharps from entering the top portion and sticking someone.The customer states apparently a needle got stuck in a gap of the hinge mechanism on the right side of the container which caused the injury.The customer further reports the container was on a counter top.The customer stated it fell over on the counter, when the individual went to pick up the container, that is when the needle stick occurred.The customer stated the individual has received blood tests, there are no results at this time.The customer stated he took a base line titer and then would go in two weeks for a second titer.

Manufacturer Narrative

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

• Brand Name: SAG14-827-122 FISHER 5QT RED
• 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: 3982666
• MDR Text Key: 12422761
• Report Number: 1424643-2014-00008
• 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: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 07/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 31323176
• Device Catalogue Number: 31323176
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other