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

Model Number 8506Y

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

The customer reported that the staff had a near miss (needle stick) when trying to push the vacutainer in.The container that was not overfilled.

Manufacturer Narrative

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

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.

Event Description

The customer reported that the staff had a near miss when trying to push the vacutainer in.The container that was not overfilled.Additional information received on 08feb2023 the customer stated that when you put blood culture vacutainer adaptors into these sharps containers, they actually don¿t fit, and block it from opening/closing for future sharps.Essentially it means you can¿t put these in or it will mean even if the container isn¿t full it will need to be replaced early.

Manufacturer Narrative

Added information to section b5 and e1 based on additional details provided by the initial reporter.

• 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: 16315285
• MDR Text Key: 309255171
• Report Number: 1282497-2023-10734
• 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
• 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: 02/09/2023; 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