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

Model Number	8506Y
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
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 states an employee reported that there was a bloodwork needle sticking (not retracted) out of the sharps container, while writer was disposing iv sharps and was subsequently poked.There was a vacutainer that had not fallen completely in the container and the tumbler had not engaged.The staff didn¿t see the needle sticking out and reached for the container.They said that the container was not full.
Additional Manufacturer Narrative
Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Added additional information to section b5 and added the facility name and address to section e1 based on additional information received on (b)(6) 2023.Corrected h6 health effect - clinical code to 2462.Corrected h6 health effect - impact code to 4613.
Event or Problem Description
The customer states an employee reported that there was a bloodwork needle sticking (not retracted) out of the sharps container, while writer was disposing iv sharps and was subsequently poked.There was a vacutainer that had not fallen completely in the container and the tumbler had not engaged.The staff didn¿t see the needle sticking out and reached for the container.They said that the container was not full.Additional information received on (b)(6) 2023 stated that as a precaution the employee went to emergency and saw a physician.They also had blood work done as a precaution, the results are not available.

• Brand Name: 5QT.CNT.W/TRNS YELLOW CONT. 20
• Common Device Name: CONTAINER, SHARPS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16315077
• Report Number: 1282497-2023-10733
• Device Sequence Number: 15656708
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2023

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 Model Number: 8506Y
• Device Catalogue Number: 8506Y
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 01/23/2023; 01/23/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 02/15/2023; 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown