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

Model Number	8881850558
Medical Device Problem Codes	Use of Device Problem (1670); Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment - the customer stated that the device will not be returned for evaluation because it has been discarded.
Event or Problem Description
Customer reports: the needle didn¿t activate the safety needle feature and poked the nurse.Per additional information provided by the customer, the needle stick occurred with a used needle and protocol for employee health was conducted.There is no additional testing or procedure required that we have been made aware of.
Additional Manufacturer Narrative
A review of the device history records (dhr) yielded no discrepancies within the manufacture of the affected lot number reported.There were no samples or photos submitted with this complaint therefore the reported condition could not be confirmed.The exact root cause could not be determined based on available information.There is insufficient information to determine if the true root cause.Prior to a lot¿s release, the lot must be deemed acceptable, passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples are inspected for shield defects.The lot met all defined acceptance requirements and was released.There were no anomalies found during a review of the dhr¿s, maintenance records or process monitoring data.There was no evidence of any systemic failure of the manufacturing process.Also, there was no trend observed.Based on the investigation and root cause analysis, the initiation of a new corrective/preventative action (capa) is not required.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: SAFETY NEEDLE 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; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15552556
• Report Number: 1017768-2022-01031
• Device Sequence Number: 2797301
• Product Code: FMI
• UDI-Device Identifier: 10884521000575
• UDI-Public: 10884521000575
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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
• Device Model Number: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 201040
• 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: 09/26/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/09/2022
• 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