MAUDE Adverse Event Report: COVIDIEN SHARPS CONTAINER 12GAL SLIDE-; CONTAINER, SHARPS

Model Number	8936PG2
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported the container lid is difficult to close.After several attempts to close, the lid continues to lift.It took about 5 minutes with each container with continued attempts at closing the lid to succeed.Containers were closed properly after many attempts and sent for proper disposal.

• Brand Name: SHARPS CONTAINER 12GAL SLIDE-
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11740649
• Report Number: 1424643-2021-00595
• Device Sequence Number: 16920239
• Product Code: MMK
• UDI-Device Identifier: 40884521022431
• UDI-Public: 40884521022431
• 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
• Report Date (Section B): 04/28/2021

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: 8936PG2
• Device Catalogue Number: 8936PG2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1