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

Model Number	8507SA
Medical Device Problem Code	Nonstandard Device (1420)
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.
Event or Problem Description
The customer reported that the lid didn't fit the container they ordered because it was too small.

• 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: 9135638
• Report Number: 1424643-2019-00546
• Device Sequence Number: 3007610
• Product Code: MMK
• UDI-Device Identifier: 10884521023284
• UDI-Public: 10884521023284
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2019

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: 8507SA
• Device Catalogue Number: 8507SA
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 09/30/2019
• Patient Sequence Number: 1