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)
Date of Event	08/18/2023
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: another hypodermic safety needle leaked for one of our rns in the newborn nursery on friday, august 18th, when she was performing a circumcision on a baby.
Additional Manufacturer Narrative
The batch record: production sites checked the batch record of monoject hypodermic safety needle 27g*1/2" lot 02208035 ref involved in the complaint with no anomalies found in the batch documentation.A visual check of 20 pieces of the retained samples were visually inspected.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 lack of glue or less glue were found.Five pcs of archive 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.Iso 80369 verification: confirmed that safety needle hub measures comply with en iso 80369-7:2021.Customer samples were provided, and a visual inspection of the samples show the needle is combined with a non-sol-m syringe and the safety mechanism is already activated.Plastic components are intact and properly assembled.The connection between the two devices is securely maintained in accordance with iso 80369-7:2021.In order to verify the reported issue, the safety arm was removed.Water was drawn up without any observable leakage, then to simulate the pressure of injection, the needle was plugged with rubber to block flow.At this point, the injection was simulated with no water leakage observed.The reported issue is unconfirmed, based on the investigation, therefore a root cause cannot be established.The manufacturing site 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 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: 17618950
• Report Number: 1282497-2023-10774
• Device Sequence Number: 14103068
• 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): 03/08/2024

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: 08/21/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 03/08/2024
• 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