MAUDE Adverse Event Report: COVIDIEN 2 GA N/S COLL CONT YELLOW 20; CONTAINER, SHARPS

Model Number	8970Y
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested but to date has not yet been received.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.
Event or Problem Description
Customer reports: despite instructions on how to lock the circular closure, they were unable to close the container.
Additional Manufacturer Narrative
Based on the reported event and details provided, neither a manufacturing nor design defect could be confirmed.It is most probable that the failure is associated with a use error.Precautions/warnings supplied with the device clearly state that users shall never put hands into container opening and provide adequate instructions for locking the rotor door.Furthermore, the height of installation of the sharps container is not controlled by the manufacture and recommendations are provided by niosh.The national institute for occupational safety and health (niosh) provides guidance in the publication of ¿selecting, evaluating and using sharps containers¿ for the ideal standing installation height for a fixed sharps disposal container.It is not known if the customer referred this standard or if a different method for determining the height of the container was selected.This investigation determined that further investigation is not required.If additional information is obtained this complaint may be reopened.This complaint will be tracked and trended to ensure the issue is not systemic.

• Brand Name: 2 GA N/S COLL CONT YELLOW 20
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 8593193
• Report Number: 1424643-2019-00537
• Device Sequence Number: 14001641
• Product Code: MMK
• UDI-Device Identifier: 40884521018380
• UDI-Public: 40884521018380
• 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): 09/16/2019

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: 8970Y
• Device Catalogue Number: 8970Y
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1