MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NDL 25 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182510
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/14/2023
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 faulty safety device (multiple needle sticks).
Additional Manufacturer Narrative
Correction made to the verbiage in section b5.
Event or Problem Description
The customer reported a faulty safety device.Additional information received on 06nov2023 stated that when you went to close the safety clip it either bent the needle or the clip did not click into place leaving the needle exposed resulting in a needle stick.Blood work was done on the patient and employee involved per their protocol.
Additional Manufacturer Narrative
Added additional information to section b5 and updated the health effect - impact code.
Event or Problem Description
The customer reported faulty safety device (multiple needle sticks).Additional information received on 06nov2023 stated that they cannot say an exact number but the product was cheaply made so when you went to close the safety clip it either bent the needle or the clip did not click into place leaving the needle exposed.They had two needle sticks.Blood work was done on the patient and employee involved per their protocol.
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 1
• 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: 18016562
• Report Number: 1282497-2023-10802
• Device Sequence Number: 7582062
• Product Code: FMI
• UDI-Device Identifier: 10884521544680
• UDI-Public: 10884521544680
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup,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
• Device Model Number: 1182510
• Device Catalogue Number: 1182510
• Device Lot Number: 02112003
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/14/2023; 09/14/2023; 09/14/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/15/2023; 11/30/2023; 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