MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NDL 27 X 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182705
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: we had an issue when using the monoject 27ga needle for lidocaine for a circumcision, it leaked around the hub.
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.
Additional Manufacturer Narrative
The device history record file was reviewed, and no discrepancy was found according to the reported condition.There were no customer samples or additional evidence provided for evaluation.A visual inspection of 20 pieces of the retained samples was carried out.All the retained samples were qualified in appearance.In addition, there were obvious glue traces in the position of the needle holder, and no problems of insufficient glue were found.Additionally, 5 pieces of archived samples were checked for clinical use.In this case, the needles were combined with a luer slip syringe to verify conical fitting of the needle.No anomalies were found.Based on the analysis performed, there is no evidence of quality defects for the monoject hypodermic safety needle 27g*1/2" lot 02208035.Regardless, retraining has been arranged at the manufacturer¿s partner to inform relevant personnel of the potential failure and prevent an occurrence.We will continue to monitor this kind of issue and further evaluations and corrective actions will be taken if necessary.

• Brand Name: MONOJECT SAFETY NDL 27 X 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 17465408
• Report Number: 1282497-2023-10769
• Device Sequence Number: 7106205
• Product Code: FMI
• UDI-Device Identifier: 10884521544765
• UDI-Public: 10884521544765
• 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
• Report Date (Section B): 10/12/2023

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: 1182705
• Device Catalogue Number: 1182705
• Device Lot Number: 02208035
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 10/12/2023
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown