MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NDL 25 X 5/8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182558
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the rn pulled up an immunization xx into a 3 cc syringe using a blunt needle.Afterward rn replaced with a hypodermic safety needle.Rn was able to prime the needle without event.Rn cleansed the patient's skin with an alcohol swab.This rn gently squeezed the skin on the right vas lateralis with left hand and injected needle at a 90-degree angle with a quick thrust with the right.Rn used no more force than this rn typically uses for im injection.When injection was given all or most of the immunization expelled out the side of the syringe along the luer lock of the needle.Upon inspection of the needle after injection, the needle was slightly bent and the hypodermic safety needle itself looked damaged at the luer lock site.Additional information received on 26oct2023 stated that they used the needle with a bd plasti pak 3 ml syringe lot 2181846.They twisted the hub into the luer until it would not twist anymore.The needle did not appear to be bent prior to the injection.The area that looked damaged was the hub where it attaches to the luer lock.It was as if the entire device shifted forward starting at a bend in the hub.This was not noticed when the needle was applied to the syringe or the needle was being primed.They did not notice the needle was bent until after they had applied the shield so at the time they were not sure if this occurred during the injection or when they applied the safety shield as it is a habit to automatically apply the shield when removing the needle.The entire needle device was bent forward in a way that the safety did not cover the tip.The entire needle appeared to bend forward away from the safety shield and the deformity/bend in the hub appeared to be under below the safety shield attachment site.The patient will need to return another day to make up the immunization however there was nothing unusual about the injection site.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
This report was filed in error.Cardinal health is not the legal manufacturer of this this device.The legal manufacturer is sol millennium med inc.The manufacturer has been notified of the event.

• Brand Name: MONOJECT SAFETY NDL 25 X 5/8
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 18126597
• Report Number: 1282497-2023-10807
• Device Sequence Number: 20424370
• Product Code: FMI
• UDI-Device Identifier: 10884521544710
• UDI-Public: 10884521544710
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2024

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
• Operator of Device: Health Professional
• Device Model Number: 1182558
• Device Catalogue Number: 1182558
• Device Lot Number: 02105048
• 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: 10/25/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown