MAUDE Adverse Event Report: COVIDIEN 8 GA RENEWABLES SLIDE LID; CONTAINER, SHARPS

Model Number	8980S
Medical Device Problem Codes	Break (1069); Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the lid cannot be attached and plastic parts break off when attempting to attach it.The customer also reported the cap that seals the lid is inserted the wrong way.

• Brand Name: 8 GA RENEWABLES SLIDE LID
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 10462090
• Report Number: 1424643-2020-00582
• Device Sequence Number: 11360663
• Product Code: MMK
• UDI-Device Identifier: 30884521022489
• UDI-Public: 30884521022489
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 8980S
• Device Catalogue Number: 8980S
• Device Lot Number: DES.360,062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1