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

Model Number	8537SA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional 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
• 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: 18480974
• Report Number: 1282497-2024-00001
• Device Sequence Number: 6398800
• Product Code: MMK
• UDI-Device Identifier: 20884521077253
• UDI-Public: 20884521077253
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/12/2023
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 02/06/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown