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

Model Number 8506Y

Device Problem Mechanical Problem (1384)

Patient Problems Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 309369678
• Report Number: 1282497-2023-10733
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 10884521023260
• UDI-Public: 10884521023260
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 01/23/2023; 01/23/2023
• Supplement Dates FDA Received: 02/15/2023; 02/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1