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

Model Number 8881850510

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

Customer reports: the product is leaking fluid out of the needle.

• Brand Name: SAFETY NEEDLE 25 G X 1"
• Type of Device: 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
• MDR Text Key: 338896109
• Report Number: 1017768-2024-00034
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10884521000568
• UDI-Public: 10884521000568
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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
• Date Manufacturer Received: 03/19/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1