MAUDE Adverse Event Report: CARDINAL HEALTH 16G X 5 8 B ALUM HUB RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881200755
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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
The customer reported that the needle came out of the hub and they had to dig it out of the calf (cow).
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.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.Specifically, the needles were inspected for pull testing of cannula below specification.The lot met all defined acceptance requirements and was released.One box of unused samples was received for evaluation.The samples were visually, dimensionally, and functionally tested per procedure; no issues were found.A photo was also provided.A review of the provided photo confirmed the reported issue.A 6m root cause investigation was conducted and reviewed multiple contributing factors, however based on available information, the exact root cause could not be determined as there were no anomalies found during a review of the dhr, maintenance records or process monitoring data.Furthermore there was no evidence of any systemic failure of the manufacturing process.Based on all available information, the initiation of a corrective and preventive action (capa) is not required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 16G X 5 8 B 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: 15032840
• Report Number: 1017768-2022-01017
• Device Sequence Number: 12497441
• Product Code: FMI
• UDI-Device Identifier: 30884521008797
• UDI-Public: 30884521008797
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2022

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: 8881200755
• Device Catalogue Number: 8881200755
• Device Lot Number: 111706
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown