MAUDE Adverse Event Report: CARDINAL HEALTH SAFETY NEEDLE 21 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850110
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/02/2022
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 a paramedic suffered a needle stick from a dirty needle.The safety cap failed on the device.Per additional information received, the employee has resumed working and is being followed by occupational health for bloodborne exposure.
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.The physical sample was not returned; however, a photograph was provided for reference.Based solely on a visual inspection of the photograph, the reported condition could not be confirmed.Based on this analysis, the root cause could not be determined.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 defects.The lot met all defined acceptance requirements 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.Based on the investigation and root cause analysis, the initiation of a new corrective/preventative action (capa) is not required.The complaint shall be reopened if a sample is received.This complaint will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: SAFETY NEEDLE 21 X 1
• 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: 15573553
• Report Number: 1017768-2022-01032
• Device Sequence Number: 2796995
• Product Code: FMI
• UDI-Device Identifier: 10884521000513
• UDI-Public: 10884521000513
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 8881850110
• Device Catalogue Number: 8881850110
• Device Lot Number: 008353
• 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: 09/12/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 10/10/2022
• 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