MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NDL 18 X 1.5; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1181815
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 the safety part of the needle broke as soon as the clear cap was taken off the needle.This happened multiple times.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A photo provided by the customer did not show any product problem.Retained samples were visually and functionally tested.No issues were found therefore we were unable to confirm the reported issue and determine a root cause.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJECT SAFETY NDL 18 X 1.5
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 777 west steet; 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: 17759180
• Report Number: 1282497-2023-10794
• Device Sequence Number: 20496757
• Product Code: FMI
• UDI-Device Identifier: 10884521544734
• UDI-Public: 10884521544734
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2023

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: 1181815
• Device Catalogue Number: 1181815
• Device Lot Number: 02107201
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 12/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown