MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NEEDLE 19 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1181910
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: there are problems with the new needles.Staff are having problems with them drawing meds out of vials.Also the entire safety device is falling off if they aren¿t careful with them.The safety is snapping off when attaching needle to syringe.
Additional Manufacturer Narrative
The device history record did not indicate that there were any issues during the manufacturing of this lot.A product analysis was unable to be completed as to date no samples have been provided.A photo was provided and confirmed the safety shield detached from needle hub.Precluding any further information or evidence there is not enough information at this time to determine what likely caused the reported issue; therefore, the root cause is undetermined.If additional information or evidence becomes available, the complaint will be reopened and the root cause reassessed.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJECT SAFETY NEEDLE 19 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: 16914542
• Report Number: 1282497-2023-10758
• Device Sequence Number: 6355893
• Product Code: FMI
• UDI-Device Identifier: 10884521544741
• UDI-Public: 10884521544741
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/12/2023

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: 1181910
• Device Catalogue Number: 1181910
• Device Lot Number: 02107196
• 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: 05/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/12/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown