MAUDE Adverse Event Report: COVIDIEN CONTAINER SHARPS RED SLIDE LID DISP 18GL; CONTAINER, SHARPS

Model Number	8938
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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. if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the container was cracked.There was no patient injury.
Additional Manufacturer Narrative
A device history record could not be reviewed because a lot number could not be provided by the customer.Two photographs were submitted for evaluation however an actual sample was not returned.The photographs confirmed that the containers are cracked.The potential root cause for a cracked container is due to damage that can occur during shipping and handling due to external stress/forces after manufacture or the container cracked due to a sharp impact during use.Based on the existing controls, and the complaint history review, additional correction or containment activities are not warranted at this time.Product is routinely examined to ensure it meets all acceptance quality limits.All lots are statistically sampled and inspected for defects prior to release.A lot cannot be released unless it meets all acceptance requirements.

• Brand Name: CONTAINER SHARPS RED SLIDE LID DISP 18GL
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 9792897
• Report Number: 1424643-2020-00571
• Device Sequence Number: 3331894
• Product Code: MMK
• UDI-Device Identifier: 40884521022233
• UDI-Public: 40884521022233
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 04/22/2020

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: 8938
• Device Catalogue Number: 8938
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1