MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT SFTY INS NDL 29X1/2 1.0ML; SYRINGE, PISTON

Model Number	8881511110
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/19/2024
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 reported that a nurse was stuck with a used needle after attempting to engage the safety mechanism.The colleague reports that the tube that is pushed up over the needle after use and then twisted to lock became stuck halfway up and did not fully protect the needle.The colleague attempted to apply additional force to push the tube up and their hand slipped causing their hand to strike the exposed portion of the needle.Additional information received on 07feb2024 stated that the nurse went to occupational health and right after the incident, the nurse went to the ed.First aid was done and blood was drawn.All labs were negative.The nurse will have more labs drawn at the next appointment on (b)(6) 2024.
Additional Manufacturer Narrative
A sample was not received for the investigation and a device history record review could not be performed because a lot number was not received with the complaint therefore were unable to perform a follow up investigation to include functional and visual evaluations.Based on the information available to us, we were unable to confirm the event.A corrective action is not applicable at this time.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: MONOJCT SFTY INS NDL 29X1/2 1.0ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18713922
• Report Number: 1915484-2024-00003
• Device Sequence Number: 7906802
• Product Code: FMF
• UDI-Device Identifier: 20884521014937
• UDI-Public: 20884521014937
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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: 8881511110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/19/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown