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

Model Number 8506Y

Device Problem Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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
• Type of Device: CONTAINER, SHARPS
• Manufacturer (Section D): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 12586173
• MDR Text Key: 275042336
• Report Number: 1424643-2021-00618
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023260
• UDI-Public: 10884521023260
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Model Number: 8506Y
• Device Catalogue Number: 8506Y
• Device Lot Number: 21C09063
• Initial Date Manufacturer Received: 09/21/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 09/21/2021
• Supplement Dates FDA Received: 10/25/2021
• Patient Sequence Number: 1