MAUDE Adverse Event Report: CARDINAL HEALTH SAFETY NEEDLE 25 G X 1"; SYRINGE, PISTON

Model Number	8881850510
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
As reported by ecri, an anonymous ecri member reported that there was staff member needle stick injury with a used needle due to the safety does not engage all the way, so the tip of the needle is still exposed.It will click making you think it's locked and fully over the needle when it isn't.It is also extremely flimsy.The needle feels as if the safety is fully engaged but a small part of the needle remains unsheathed.They also noticed if the safety is pushed further to attempt to engage more, the needle begins to bend.Additional information received on (b)(6) 2023 stated that no first aid interventions needed, hand wash only.Labs were ordered.Blood/body fluid exposure (bbfe protocol) included rapid hiv-1, hiv-2, hep b and hep c and all resulted negative.
Additional Manufacturer Narrative
Samples were not received for the investigation.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: SAFETY NEEDLE 25 G X 1"
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18097439
• Report Number: 1017768-2023-01104
• Device Sequence Number: 12728552
• Product Code: FMF
• UDI-Device Identifier: 10192253024746
• UDI-Public: 10192253024746
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/23/2024

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: 8881850510
• Device Catalogue Number: 8881850510
• 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: 10/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 05/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown