MAUDE Adverse Event Report: COVIDIEN 18 GA HINGED CHEMO - YELLOW; CONTAINER, SHARPS

Model Number	8989
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that they found damage on the container after opening the box.Upon viewing the photos provided by the customer, the rim of the container was cracked.
Additional Manufacturer Narrative
A device history record (dhr) review found that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Photographic samples provided by the customer were reviewed and the reported issue was observed.: the physical sample was also returned for evaluation which also confirmed the reported issue.A possible root cause that could lead to his issue is if the ejection pressure/speed is too high that the rim of the container can be damaged; however, a review of the process control record found all validated parameters to be within specification.The damage may have originated during shipping, or use; however, at this time there is not enough information to determine the cause.It must be noted that the instructions for use (ifu) for this product instructs the user to check that the container ¿has suffered no shipping damage before placing into use¿.Based on the information available and the investigation findings, additional actions are not deemed necessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 18 GA HINGED CHEMO - YELLOW
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11003694
• Report Number: 1424643-2020-00587
• Device Sequence Number: 3548737
• Product Code: MMK
• UDI-Device Identifier: 30884521022816
• UDI-Public: 30884521022816
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 02/08/2021

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: 8989
• Device Catalogue Number: 8989
• Device Lot Number: 20B28063
• Initial Date Received by Manufacturer: 12/09/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 02/08/2021
• Patient Sequence Number: 1