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

Model Number	8881850558
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) 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 samples are inspected for damages/leaks.The lot met all defined acceptance requirements and was released.The product was produced between 15nov2021 and 16nov2021.There were no physical samples received with this complaint.The provided photos were reviewed but the reported condition could not be confirmed.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, maintenance records or process monitoring data.There was no evidence of any systemic failure of the manufacturing process.Also, there was no trend observed.Based on the investigation and root cause analysis, the initiation of a corrective and preventive action is not required.The investigation will be updated if a sample is received at a later date.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported that it appears that there was leakage happening at the point of the orange plastic on the needle and the steel needle.This incident involved hazardous cytotoxic medication.The needle was changed which resulted in opening a closed system and exposure of substance to nursing team.No harm to patient.Appropriate spill clean up was completed.Medication delivered to patient with new needle connected.Photos attached.Additional information received on 29nov2022 stated that the medication was rituximab.The nurses were exposed to the drug as a result of the leaking device.They were wearing appropriate ppe so exposure was a non-event.This occurred when attempting to administer medication to patient.The needle was replaced and medication administered.No patient injury and medical invention was required.

• 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: 15954394
• Report Number: 1017768-2022-01038
• Device Sequence Number: 7334997
• Product Code: FMI
• UDI-Device Identifier: 20884521000572
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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 Expiration Date: 09/30/2026
• Device Model Number: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 133394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Initial Report FDA Received Date: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown