MAUDE Adverse Event Report: CARDINAL HEALTH MONOJECT SAFETY NDL 25 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182510
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the nurse was holding the syringe in her right hand and while inserting it into the sharps box, holding the flap with her left hand, poked her left index finger.She believed that she had engaged the safety with the right thumb before discarding, but it apparently it had not engaged.There was no medical intervention required and there was no patient injury.
Additional Manufacturer Narrative
The device history record review concluded that there were no related issues recorded throughout the manufacturing and control processes.The manufacturing records were reviewed for the reported lot and no related event occurred during the overall process for this lot.The manufacturing site has not received any samples or photographs with this customer report.There were no anomalies found on testing of five archived samples from the same lot.It is recommended that a hard surface activation or thumb activation with no sliding motion is used for the safety needle.In the case there is no hard surface available, use your thumb to push the safety shield over the needle until an audible ¿click¿ signal is perceived.This indicates proper activation of the safety mechanism.The needle is fully covered by the safety shield.Discard used device into a sharps container according to facility protocol.There is no evidence of a trend therefore no immediate corrective action is required.We will continue to monitor the product for a reoccurrence or trend.

• Brand Name: MONOJECT SAFETY NDL 25 X 1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 110 kendall park ln; atlanta GA 30336
• Manufacturer (Section G): CARDINAL HEALTH; 110 kendall park ln; atlanta GA 30336
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12912800
• Report Number: 1282497-2021-10659
• Device Sequence Number: 20038738
• Product Code: FMI
• UDI-Device Identifier: 10884521544680
• UDI-Public: 10884521544680
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: 1182510
• Device Catalogue Number: 1182510
• Device Lot Number: 02010014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/08/2022
• 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