MAUDE Adverse Event Report: COVIDIEN CONTAINER SHARPS 5QT RED; CONTAINER, SHARPS

Model Number	8507SA
Medical Device Problem Code	Component Incompatible (1108)
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 lids do not fit the sharps containers.
Additional Manufacturer Narrative
Please disregard this report number 1424643-2020-00575 after receipt of the sample from the customer, the investigation determined that cardinal health is not the manufacturer of the device.This report was submitted in error as the incident reported by the customer does not meet the mdr regulation requirements of a reportable event, as we are not the legal manufacturer for this particular device.

• Brand Name: CONTAINER SHARPS 5QT RED
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9981918
• Report Number: 1424643-2020-00575
• Device Sequence Number: 4597417
• Product Code: MMK
• UDI-Device Identifier: 10884521023284
• UDI-Public: 10884521023284
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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): 05/14/2020

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: 8507SA
• Device Catalogue Number: 8507SA
• Device Lot Number: 20A01163
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1