MAUDE Adverse Event Report: COVIDIEN 3GA ALWAYS OPEN INROOM -T RED; CONTAINER, SHARPS

Model Number	85221R
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
A video was provided by the customer and upon reviewing the video, it was noticed that the customer was removing the lid from the container and the lid cracked.This was noticed prior to use and no patient was involved.
Additional Manufacturer Narrative
A device history record (dhr) review could not be reviewed because the lot number was reported as unknown, however all dhr¿s are reviewed for accuracy prior to product release.A video was provided by the customer and upon reviewing the video, it was noticed that the customer was removing the lid from the container and the lid cracked.It was determined that the customer/user violated numerous instructions in the instruction for use (ifu) including: instruction: place container in wall enclosure or bracket and lock with key if it is a locking unit.Precautions/warnings: never put hands into container opening.Never attempt to disassemble container.Do not strike, tap, shake, or manipulate container for any reason.Use container with appropriate covidien hardware that fits with the covidien container of choice.The root cause of the lid breaking was use error (removing the lid).The reported complaint was not related to a manufacturing issue.No adverse trending in internal non-conformances or complaints related to this issue were identified.

• Brand Name: 3GA ALWAYS OPEN INROOM -T RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 10597457
• Report Number: 1424643-2020-00584
• Device Sequence Number: 11060763
• Product Code: MMK
• UDI-Device Identifier: 10884521023369
• UDI-Public: 10884521023369
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 85221R
• Device Catalogue Number: 85221R
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/07/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1