MAUDE Adverse Event Report: COVIDIEN 8 GAL NDL DISP CONT YELLOW 10; CONTAINER, SHARPS

Model Number	8980Y
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer reported the cover is not closing properly on the sharps container, leaving needles exposed.
Additional Manufacturer Narrative
A review of the device history record (dhr) was completed for lot 18e18663.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.Two photographs were provided for analysis.One photograph shows the hinged lid resting on top of the container perpendicular to the correct alignment.It is not clear if that is the cause of the reported issue of lid not closing properly and for the purposes of this analysis it will be assumed that it is not.The second photograph shows the label and does not contribute to understanding what caused the reported issue.Therefore, the product evaluation based on the two photographs provided is inconclusive.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.If additional information or the physical sample is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 8 GAL NDL DISP CONT YELLOW 10
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 8772363
• Report Number: 1424643-2019-00540
• Device Sequence Number: 11336987
• Product Code: MMK
• UDI-Device Identifier: 30884521022496
• UDI-Public: 30884521022496
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8980Y
• Device Catalogue Number: 8980Y
• Device Lot Number: 18E18663
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 10/04/2019
• Patient Sequence Number: 1