MAUDE Adverse Event Report: CARDINAL HEALTH HYPO NEEDLE 23G X 3/4 A BEV RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881250289
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needle detaches from the hub.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A review of the device history records (dhr) yielded no discrepancies within the manufacture of the affected lot number reported.All quality assurance testing performed during manufacturing was acceptable.There were no samples/photos submitted with this complaint.The reported condition could not be confirmed.The exact root cause could not be determined based on available information.The investigation analysis did not identify any issues with the manufacturing process that would have caused this issue.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, the needles were inspected for pull testing of cannula below specification.The lot met all defined acceptance requirements and was released.The true root cause of the failure could not be determined based on available information.There were no anomalies found during a review of the dhr¿s, maintenance records or process monitoring data.There was no evidence of any systemic failure of the manufacturing process.Based on the investigation and root cause analysis, the initiation of a new corrective/preventative action is not required.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: HYPO NEEDLE 23G X 3/4 A BEV 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: 15539657
• Report Number: 1017768-2022-01028
• Device Sequence Number: 7073921
• Product Code: FMI
• UDI-Device Identifier: 20884521013800
• UDI-Public: 20884521013800
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/03/2022

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: 8881250289
• Device Catalogue Number: 8881250289
• Device Lot Number: 214304
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 11/04/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown