MAUDE Adverse Event Report: COVIDIEN 5 QT MAILBOX INROOM - CLEAR; CONTAINER, SHARPS

Model Number	85121
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2019
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the lid of the sharps container breaks.When shutting the lid, their hand almost goes inside the item.When pushing in the left hand side of the orange portion, it completely collapses and it doesn't allow them to push down on it at all because it falls right inside.
Additional Manufacturer Narrative
A review of the device history record was completed.The dhr review concluded that no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One (1) sample was received for the evaluation.The door was partially attached to the lid on the right side of the container, however, was broke on the left side.The molded pin which holds the door to the lid was cracked.The lid exhibited stress marks near the point of breakage.This is an indication that the lid encountered force after molding.The method of root cause analysis that was implemented in this investigation was to conduct a six m assessment.No definitive root cause could be identified from the investigation.It shall also be noted that related capa was initiated to investigate broken containers.The findings concluded that third party distribution centers are breaking down cases from the supplied unit of measure and repackaging them, likely contributing to field issues.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 5 QT MAILBOX INROOM - CLEAR
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9341583
• Report Number: 1424643-2019-00553
• Device Sequence Number: 19533377
• Product Code: MMK
• UDI-Device Identifier: 10884521022683
• UDI-Public: 10884521022683
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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: 85121
• Device Catalogue Number: 85121
• Device Lot Number: 19F14163
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1