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

Model Number	8881850510
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 product is leaking fluid out of the needle.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured between 11oct2022 and 12oct2022.Five opened but unused devices were returned for evaluation.Functional testing was completed per procedure; the reported issue was not observed on the returned product.Based on the available information, the reported condition could not be confirmed.A root cause was not determined.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: SAFETY NEEDLE 25 G X 1"
• 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: 18995245
• Report Number: 1017768-2024-00034
• Device Sequence Number: 2946387
• Product Code: FMI
• UDI-Device Identifier: 10884521000568
• UDI-Public: 10884521000568
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 22K503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 08/08/2024
• 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