MAUDE Adverse Event Report: CARDINAL HEALTH 3 GA SHARPSTAR - TRANS RED; CONTAINER, SHARPS

Model Number 8537SA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

The customer reported that a needle was poking out of the sharps container and customer was poked.Customer went to the hospital.Additional information received on (b)(6) 2023 stated that the employee was given medications for the treatment to prevent hiv since the needle is from an unknown source.The employee also had an hiv test and a hepatitis panel drawn.The results are negative.The employee will have follow up labs for one year.On (b)(6) 2024 the customer confirmed the needle was sticking through the wall of the container.

Manufacturer Narrative

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

Manufacturer Narrative

A sample was not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.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.

• Brand Name: 3 GA SHARPSTAR - TRANS RED
• 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: 18480974
• MDR Text Key: 332488695
• Report Number: 1282497-2024-00001
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 20884521077253
• UDI-Public: 20884521077253
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8537SA
• Device Catalogue Number: 8537SA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2023
• Type of Device Usage: A
• Patient Sequence Number: 1