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	08/19/2022
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 an incident occurred at the orange plastic safety latch connection point with the needle, causing medication to leak from that point.The incident was caught in time and the needle was changed, which resulted in opening a closed system.There was no patient harm.The appropriate spill clean up was completed.
Event or Problem Description
The customer reported that an incident occurred at the orange plastic safety latch connection point with the needle, causing medication to leak from that point.The incident was caught in time and the needle was changed, which resulted in opening a closed system.There was no patient harm.The appropriate spill clean up was completed.Additional information was received and stated that there was no medical intervention needed.
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The device history record (dhr) for the reported lot number indicates that the product was produced between 28-apr-2021 to 29-apr-2021.A review of maintenance records (both corrective and preventive) and calibration records were reviewed, and no issues were identified.All scheduled maintenance and calibration activities were completed.There were no process or material changes related to the reported condition for this product in the 12 months prior to the production date.A review of the machine setup was conducted and revealed no issues.The equipment was reviewed for malfunctions or issues that could have contributed to the reported condition, but no such issues were observed during the review.There was no sample received for the evaluation.A picture was provided for the evaluation.Upon reviewing the picture, the reported issue is not confirmed.The exact root cause of the reported condition could not be determined without an actual sample to examine.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.At this time, a corrective and preventive action is not deemed necessary.This complaint will be used for qa tracking and trending purposes.

• 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: 15373961
• Report Number: 1017768-2022-01022
• Device Sequence Number: 6744743
• 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): 10/18/2022

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: 03/31/2026
• Device Model Number: 8881850558
• Device Catalogue Number: 8881850558
• Device Lot Number: 113757
• 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: 08/19/2022
• Supplement Date Received by Manufacturer: 08/19/2022
• Initial Report FDA Received Date: 09/07/2022
• Supplement Report FDA Received Date: 10/18/2022
• 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