MAUDE Adverse Event Report: COVIDIEN CONTAINER SHARPS 5QT RED; CONTAINER, SHARPS

Model Number 8507SA

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the needle protruded through the sharp container.Additional information received from customer stated that no injuries were sustained as a result of this incident.The issue was noticed during a routine equipment check.

Manufacturer Narrative

A review of the device history record (dhr) was completed.The dhr review concluded no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.To date, no samples were returned for analysis, however photographs were supplied.One needle was observed protruding through the surface, estimated at approximately 1¿ from the bottom.The needle appeared to protrude an estimated 0.25¿.Based on the pictures supplied, it does not appear that the container was filled above the established ¿full¿ line.Device printing can be seen through the container to the opposite side.The method of root cause analysis implemented in this investigation was to conduct a six m assessment that evaluated potential causes.There was not enough information available to determine a root cause; however, if the instructions for use (ifu) are not adhered to, the described condition could occur.The ifu states: (1) ¿use one hand to place sharp in slot horizontally, making sure sharp falls into container.Lift to assure sharp drops.Do not dispose of more than one item at a time.¿ (2) ¿container is full if door does not return to the open position or the ¿full¿ indicator is visible.The use and contents of this container may dictate earlier disposal, but in no event should the container be more than three quarters full.The container should be changed regardless of contents when objects can no longer be dropped freely, without resistance, into the container.(3) precautions/warnings: always keep used container in upright position, use the proper size container for the items and volume being disposed, do not strike/tap/shake or manipulate container for any reason even to settle contents, use container with appropriate hardware that fits container of choice, for single use only.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: CONTAINER SHARPS 5QT RED
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9526062
• MDR Text Key: 173034786
• Report Number: 1424643-2019-00560
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023284
• UDI-Public: 10884521023284
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8507SA
• Device Catalogue Number: 8507SA
• Device Lot Number: 19F14063
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Patient Sequence Number: 1