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

Model Number	1182558
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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.H3: device evaluation comment - the customer stated that the device will not be returned for evaluation because the device was discarded.
Event or Problem Description
Customer reports: the needle falls off the syringe (packaged needle/syringe).Per additional information provided on 8/4/23 this incident occurred in (b)(6) 2023.The incident was not reported in (b)(6) because it was a one off and it seemed to be an educational/practice issue.
Event or Problem Description
Additional information provided by the customer on (b)(6)stated that in this case the needle did not detach as originally reported, however, the nurse practitioners feel that this occurs due to the manufacturing of the needing and the cap.In this case the needle leaked.
Additional Manufacturer Narrative
Section b5: describe event or problem - initially, the customer had reported that the needle detached however after receiving additional information on 8/31/23, it has been confirmed that the needle did not detach, rather it leaked therefore the description summary has been updated.Section h6: medical device problem code - initially coded as 2907 has been updated to code 1250.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• 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: 17470510
• Report Number: 1282497-2023-10770
• Device Sequence Number: 7121568
• 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,Followup
• Report Date (Section B): 10/26/2023

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: 1182558
• Device Catalogue Number: 1182558
• Device Lot Number: 101104005
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 08/02/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 08/31/2023; 10/26/2023
• 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