MAUDE Adverse Event Report: CARDINAL HEALTH 25G X 2 A ALUM HUB RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881200441
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported 3 needles were leaking at the connection site.Additional information received stated they were leaking from the hub.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing no issues with the reported lot.There were no photos or samples submitted with this complaint.The reported condition could not be confirmed.The exact root cause of the reported condition could not be determined without a sample to examine.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.The lot met all defined acceptance requirements and was released.No action will be taken because the reported condition could not be confirmed.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 25G X 2 A ALUM HUB RP
• 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: 17341764
• Report Number: 1017768-2023-01082
• Device Sequence Number: 15088930
• Product Code: FMI
• UDI-Device Identifier: 30884521008643
• UDI-Public: 30884521008643
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 11/07/2023

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: 8881200441
• Device Catalogue Number: 8881200441
• Device Lot Number: 23D118
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 11/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown