MAUDE Adverse Event Report: CARDINAL HEALTH SAFETY NEEDLE 23 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850310
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
Customer reports: the cannula leaks and liquid leaked out of the side of the plastic attachment when injecting.
Additional Manufacturer Narrative
See h4/h5 for device manufacture date.See section h6 (evaluation codes): health effect - clinical code: updated to 4582 - no clinical signs, symptoms or conditions.Type of investigation: updated to 4101 - testing of device from same lot/batch returned from user.Investigation findings: updated to 213 - no device problem found.Investigation conclusions: updated to 67 - no problem detected.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 product was manufactured on 10-nov-2020.A review of maintenance records (both corrective and preventive) and calibration records showed no issues related to the reported condition.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.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, samples are inspected for leaking.There were 2 unused samples received for the evaluation.The functional test was performed on the samples received and the reported condition could not be confirmed from the sample.A definite root cause of the reported issue could not be determined.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 issue of the manufacturing process.Based on the investigation and root cause analysis, a corrective and preventive action is not deemed necessary at this time.This complaint will be used for qa tracking and trending purposes. section e1 (initial reporter name and address - phone number): originally reported incorrectly as 011(123)1234567890.A phone number was not provided by the customer. .

• Brand Name: SAFETY NEEDLE 23 X 1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• MDR Report Key: 12448055
• Report Number: 1017768-2021-00981
• Device Sequence Number: 12033939
• Product Code: FMI
• UDI-Device Identifier: 10884521000544
• UDI-Public: 10884521000544
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2021

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
• Operator of Device: No Information
• Device Model Number: 8881850310
• Device Catalogue Number: 8881850310
• Device Lot Number: 031474
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/20/2021
• Patient Sequence Number: 1