MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; 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	09/19/2024
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 cma administered a vaccine to a patient and implemented the safety cap on the syringe by pushing the safety cap against the table.The cma then went to set the syringe on the table with their right hand and with their left hand grabbed a band-aid for the patient.The cma was stuck on the left-hand forefinger with the needle.It was stated that after the stick, the needle had unscrewed, and the vaccine's pre-filled syringe fell to the floor and that is when the cma noticed that the needle had apparently bent separating from the safety cap and had malfunctioned allowing the needle to not be protected by the safety cap.Additional information received on 11oct2024 stated that the cma was seen in employee occupational health & wellness, had blood drawn, and is on medications for prophylaxis.
Additional Manufacturer Narrative
The 510(k) number was added to section g4.
Additional Manufacturer Narrative
The device history record (dhr) could not be reviewed as no lot information was provided within the complaint.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.There were no samples returned for evaluation, therefore the affected device(s) could not be evaluated to confirm the reported failure mode.¿ as such, a root cause could not be determined.¿ ¿we will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: MONOJECT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20517237
• Report Number: 1423537-2024-00261
• Device Sequence Number: 15423991
• Product Code: FMI
• UDI-Device Identifier: 10884521544680
• UDI-Public: (01)10884521544680
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K123684
• 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
• Report Date (Section B): 01/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1182510
• Device Catalogue Number: 1182510
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 10/25/2024; 01/10/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown