MAUDE Adverse Event Report: CARDINAL HEALTH 5QT.CNT.W/TRNS YELLOW CONT. 20; CONTAINER, SHARPS

Model Number	8506Y
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
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 the counter-balanced lid on the sharps container gets stuck and jams.Sharps are not completely deposited into container and sharps are left exposed which increases risk of needlestick injury.These containers are located throughout the hospital.No patient injury reported.
Additional Manufacturer Narrative
The device history record (dhr) review concluded no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.A photograph was received for evaluation.The functionality of the device cannot be evaluated from the photograph provided; however, it appears the item being disposed of is oversized for this container.The photograph shows an item resting on the door of the sharps container.The size of the item the customer is trying to dispose of in this sharp¿s container appears to be too large for this sharps container.The instructions for use for this device provides a warning to ¿use the proper size container for the items and volume being disposed¿.A formal corrective/preventative action (capa) is deemed not necessary based on reported condition¿s risk to patient/user and trending.The issue will be monitored through routine complaint trend analysis and reviewed by a capa review board (crb) to determine if a capa becomes necessary.Based on the information available and the investigation findings, additional actions are deemed unnecessary 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: 5QT.CNT.W/TRNS YELLOW CONT. 20
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 12586173
• Report Number: 1424643-2021-00618
• Device Sequence Number: 1296585
• Product Code: MMK
• UDI-Device Identifier: 10884521023260
• UDI-Public: 10884521023260
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/25/2021

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: 8506Y
• Device Catalogue Number: 8506Y
• Device Lot Number: 21C09063
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/25/2021
• Patient Sequence Number: 1