MAUDE Adverse Event Report: COVIDIEN 3 GA SSII CONT TRANS YELLOW 10; CONTAINER, SHARPS

Model Number 8537Y

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/26/2018

Event Type  Injury  

Manufacturer Narrative

Submit date: 12/5/2018.The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that a patient was able to put their hand in the sharps container and grab a needle.The patient then proceeded to ¿stab¿ 4 security guards before he/she was apprehended.

Manufacturer Narrative

The device history record (dhr) for lot number 18c02663 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.Initial product analysis was completed based on the picture supplied.The picture displayed forced accessibility into the sharps container as reported.The container appeared to be in tact with no manufacturing defects evident.Updated product analysis was later completed upon sample receipt.A sample, not in its original packaging, was received for evaluation.The lid was assembled to the container indicating that it was prepared for use or used.Labeling on the device confirmed product code 8537y lot number 18c02663.There were no sharps in the container and it did not appear to have been previously used.It is unknown if the container supplied is a representative sample or the actual device involved in the incident; which was later emptied, cleaned and reassembled.The device is designed for single use.Cleaning and reassembling may impact performance.Evaluation of the assembled sample did not identify any manufacturing issues.The container sat upright and was stable, warning labels were adhered as expected, the lid was properly adhered to the container with all 10 snap tabs engaged, the cowel was observed through the lid to be in place and assembled, and the door was properly assembled and functioning as expected.The method of root cause analysis that was implemented in this investigation, on top of the device history record assessment and product analysis, was to conduct a design review.The product is designed with a container, lid, cowel and door.The container is designed to allow the safe deposit and collection of sharps.The container is designed to be upright and stable during use, puncture resistant, allow for visual monitoring of capacity and includes proper labeling to warn of hazardous waste inside the container.Unassembled the container includes a horizontal area of entry approximately 66in2.The lid resides on the outside of the device and is designed with an overarching hood, 10 snap tabs which engage during assembly prior to placing into use via supplied instructions for use (ifu) and locking tabs which provide for final closure when the single use device is ready for disposal.The lid design further limits horizontal accessibility to the container by taking the area of entry down to approximately 22in2.The cowel resides on the inside of the device and is designed with an under arching scoop.The cowel and lid are assembled and work together to further limit vertical accessibility to approximately a 43° angle which is directly above the lids overarching hood.This requires a curling of the fingers/hand/wrist if entry were attempted.The door resides on both the inside and outside of the device.It is designed to freely ride in between the lids hood and cowel scoop during use.It includes a counter balance mechanism that essentially completely encloses the area of entry when not in use or is full.This provides the customer with an economical forced horizontal drop that maximizes container volume while minimizing the potential for overfilling by stopping in the ¿full¿ position when it reaches maximum capacity.The door is also designed to include locking tabs which are used in conjunction with the lid locking tabs for final closure/disposal.All components are made from polypropylene (pp).Pp is a thermoplastic polymer used in a wide variety of applications.Pp properties are similar to polyethylene, but it is harder and more heat resistant.It is a mechanically rugged material and has a high chemical resistance.Polypropylene is known to be tough, have a good resistance to fatigue, yet provides necessary flexibility.Together; the lid, cowel and door provide a unique design that limits accidental or intentional access to container contents.However, if force is used the pp can be bent enabling limited access to container contents.Based on the information available and investigation findings, additional actions from the manufacturer are deemed unnecessary at this time.Instructions for use (ifu) are available to the customer which detail assembly, stabilization, use, filling/overfilling and final closure/lock instructions as well as precautions/warnings.It is recommended that considerations be made on wall bracket height when installing in high risk environments.The reported customer complaint could not be confirmed.The most probable root cause was determined to be user error.This complaint will be used for tracking and trending purposes.

• Brand Name: 3 GA SSII CONT TRANS YELLOW 10
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 8135590
• MDR Text Key: 129433177
• Report Number: 1424643-2018-00515
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8537Y
• Device Catalogue Number: 8537Y
• Device Lot Number: 18C02663
• Date Manufacturer Received: 11/08/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other