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

Model Number	8881850558
Medical Device Problem Code	Fluid/Blood Leak (1250)
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.
Event or Problem Description
Customer reports: the nurse had to stop treatment due to the needle leaking.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A sample evaluation could not be conducted since a sample nor photograph was provided for evaluation.Without a sample to evaluate, it is not possible to confirm the reported issue.All associated lot documentation was carefully reviewed; no issues or discrepancies were found related to the reported complaint.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, this lot was inspected for leakage at the hub.The lot met all defined acceptance requirements and was released.Current process controls are executed in accordance with product specifications to meet quality acceptance criteria.The investigation did not identify a systemic issue with the product or process, no trend exists for the reported condition and a specific root cause could not be identified based on available information.Therefore, a corrective and preventive action (capa) is not necessary at this time.

• 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 ; 8006183640
• MDR Report Key: 16218744
• Report Number: 1017768-2023-01042
• Device Sequence Number: 17650502
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 22G278
• 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: 01/19/2023
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/03/2023
• 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