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

Model Number	85221
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The customer states that the top of the container is broken.

• Brand Name: 3GA ALWAYS OPEN INROOM -CLEAR
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 8930872
• Report Number: 1424643-2019-00542
• Device Sequence Number: 2541386
• Product Code: MMK
• UDI-Device Identifier: 40884521022707
• UDI-Public: 40884521022707
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2019

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: 85221
• Device Catalogue Number: 85221
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 08/26/2019
• Patient Sequence Number: 1