MAUDE Adverse Event Report: CARDINAL HEALTH SAFETY NEEDLE 25 X 5 8; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850558
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: this is a safety complaint.A needlestick injury occurred with a staff member during patient use.The rn administered an injection; when attempting to activate the protective cover over the needle, the cover would only advance halfway and was stuck leaving the needle exposed leading to a needlestick injury to staff.Bloodwork was done to monitor the staff member as medical intervention.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment: the customer stated that the device will not be returned for evaluation but did not provide rationale.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition as described by the customer.There were no samples or pictures submitted with this complaint therefore the reported condition could not be confirmed.The exact root cause of the reported condition could not be determined without an actual sample or photos to examine.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, samples are inspected for shield stall/locking failure and hinge pull test.The lot met the acceptance criteria and was released.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.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: SAFETY NEEDLE 25 X 5 8
• 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: 16529891
• Report Number: 1017768-2023-01047
• Device Sequence Number: 11418195
• Product Code: FMI
• UDI-Device Identifier: 10884521000575
• UDI-Public: 10884521000575
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2023

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: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 22M170
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/05/2023
• 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