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

Model Number	85221R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The manufacturing site performed a visual inspection of the sample received.During their evaluation, the investigator observed that the lid was cracked.The root cause of the cracked lid could not be determined.Therefore, a corrective and preventive action (capa) is not applicable at this time.A quality alert will be issued for the observed issue.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.
Event or Problem Description
The manufacturing site performed a visual inspection of the sample received on (b)(6) 2020.During their evaluation, the investigator observed that the lid was cracked.

• 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: 10867922
• Report Number: 1424643-2020-00585
• Device Sequence Number: 11570251
• 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: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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
• Device Lot Number: 20C07463
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/19/2020
• Patient Sequence Number: 1