MAUDE Adverse Event Report: CARDINAL HEALTH 3ML SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	8881540133
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: when drawing up medications the side of vial access cannula starting shooting out the medication.It seems like there is a hole in the plastic.It is not related to the cannula being loose on the syringe because it was tightened when syringe appeared to be leaking.
Additional Manufacturer Narrative
A device history record (dhr) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received one unused, opened packaged sample with this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted and confirmed the reported issue.The actual root cause of the reported condition could not be determined based on the available information.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.A 6m analysis was performed to identify the potential root cause.The most likely root cause could be sink or void that causes a hole to form on thinner parts of the hub mostly between the ribs during the molding process but cannot be confirmed.Corrective actions are being documented under a formal corrective/preventative action (capa) which was opened to investigate similar types of issues.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 3ML SMARTIP MED-PREP CANNULA
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 14790465
• Report Number: 1017768-2022-01014
• Device Sequence Number: 5935680
• Product Code: GEA
• UDI-Device Identifier: 10884521082946
• UDI-Public: 10884521082946
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/10/2022

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: 8881540133
• Device Catalogue Number: 8881540133
• Device Lot Number: 129832
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 06/20/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 10/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown