MAUDE Adverse Event Report: COVIDIEN 7 GA SHARPS CONTAINER; CONTAINER, SHARPS

Model Number	31156550
Medical Device Problem Codes	Component Incompatible (1108); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 containers do not sit flush on a surface.Additional information was received from the customer that when sealing the sharps for proper disposal, the latches that keep the lid locked are not secure and re-open.Also, the sharps do not have a flat bottom where the sharps can sit flush to the table, desk or computer cart.When that happens it tends to get moved around leading to tipping over.If the sharps are full enough, it has caused a spillage of used sharps.

• Brand Name: 7 GA SHARPS CONTAINER
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9873907
• Report Number: 1424643-2020-00573
• Device Sequence Number: 11559101
• Product Code: MMK
• UDI-Device Identifier: 30884521042838
• UDI-Public: 30884521042838
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 03/24/2020

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: 31156550
• Device Catalogue Number: 31156550
• Device Lot Number: 255029
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/24/2020
• Patient Sequence Number: 1