MAUDE Adverse Event Report: COVIDIEN 065 1 QUART PHLEBOTOMY CONTAINER; CONTAINER, SHARPS

Model Number 065

Device Problems Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

Submit date: 7/12/2018.The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reported: a needle went through the sharps container and stuck me when i went to place it in our biohazard waste.

Manufacturer Narrative

Submit date: 8/30/2018 the original report was submitted with the incorrect item code.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

An investigation was performed for the reported customer complaint: ¿customer reported: a needle went through the sharps container and stuck me when i went to place it in our biohazard waste.¿ all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.An internal review of inspection rejects for this particular issue was performed and resulted in no internal inspection reject for this product family.The complaint provided limited information.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The potential root cause associated with this event is improper handling/carrying of a filled sharps container for disposal by the user.There was no information in the complaint regarding the fill level of the container.The instructions for use (ifu) carrying/lifting instructions indicate: never hold or carry used container below recommended fill line and use additional caution with containers that do not have handles.Also the ifu cautions: do not hold or carry container close to the body.Additionally, there is a caution on the label stating: forcing could cause puncture.This issue has been determined to be an isolated event.The potential root cause associated with this event is improper handling/carrying of a filled sharps container for disposal by the user.Based on the existing controls and the internal reject review, no formal investigation is required at this time.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: 065 1 QUART PHLEBOTOMY CONTAINER
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek dr; crystal lake IL 60014 8172
• MDR Report Key: 7683686
• MDR Text Key: 113868597
• Report Number: 1424643-2018-00007
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 065
• Device Catalogue Number: 065
• Device Lot Number: CL63R4422A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other