MAUDE Adverse Event Report: COVIDIEN SHARPS CONTAINER 8GAL RED; CONTAINER, SHARPS

Model Number	8997PG2
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2019
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 that the white lids do not fit properly on the container.
Additional Manufacturer Narrative
Correction: e 1: facility name updated.Additional information: e 1: facility address, city, state, zip code, and phone number added.

• Brand Name: SHARPS CONTAINER 8GAL RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9580263
• Report Number: 1424643-2020-00563
• Device Sequence Number: 18955488
• Product Code: MMK
• UDI-Device Identifier: 30884521022519
• UDI-Public: 30884521022519
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 01/15/2020

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: 8997PG2
• Device Catalogue Number: 8997PG2
• Device Lot Number: 19F01563
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/13/2020
• Supplement Report FDA Received Date: 01/15/2020
• Patient Sequence Number: 1