MAUDE Adverse Event Report: COVIDIEN 2 GAL CONTAINER, TRANS YELLOW; SHARPS CONTAINER

Model Number 31300878

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/25/16.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a sharps disposal container.Customer reports that there are visible cracks.The device will be returned for evaluation.

Manufacturer Narrative

Submit date: 06/29/2016.A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The sample photos were received; the containers are cracked on the top rim area and bottom.A review of changes to product and process has been conducted identifying no affecting changes in the previous 12 months.There were no machine issues that contributed to this issue.The container may be cracked during shipping and handling.There were no material issues that contributed to this issue.There were no measurement issues that contributed to this issue.There were no manpower issues that contributed to this issue.There were no mother nature issues that contributed to this issue.This issue has been determined to be an event with minimal risk as damaged container should not be used.Before use container/lid needs to be inspected for any damage.As per complaint notes, the outer box was not damaged.The container was inspected for cracks prior to use.Several stacked containers were cracked in a row.The product was shipped from medtronic to the distributor to the customer.The potential root cause has been determined to be container cracked during shipping and handling due to external stress/forces and environmental condition (temperature).Based on the existing controls, the internal reject and the complaint history review, additional correction or containment activities are not warranted at this time.No corrective action is required at this time.Although there have been no trends identified for this product, this complaint will be used for tracking and trending purposes.

• Brand Name: 2 GAL CONTAINER, TRANS YELLOW
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): COVIDIEN; 815 tek drive; crystal lake IL 60014 9002
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5604293
• MDR Text Key: 44222323
• Report Number: 1424643-2016-00005
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 31300878
• Device Catalogue Number: 31300878
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2016
• 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