MAUDE Adverse Event Report: COVIDIEN 3ML BLUN TIP VIAL ACCESS COMBO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881541307
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2021
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 the monoject vial access cannula was opened to find a contaminant in the blunt tip.It was noticed prior to using, so no patient was harmed.
Additional Manufacturer Narrative
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.A review of maintenance records (both corrective and preventive) and calibration records were evaluated and there were no issues.All scheduled maintenance and calibration activities were completed.There were no process or material related changes to the reported condition for this product was observed.There were no physical sample received for the evaluation.One picture was provided for the evaluation.Upon analysis, the issue identified was most likely due to inclusions of burnt acrylic plastic imbedded into the cannula due to extended heating of the product during the molding process.A review of the molding process did not find any deviation within the temperature reaching outside of validated parameter.A review of ncrs in the range of the production molding was performed and did not find any instance of inclusions recorded.The exact root cause could not be determined based on available information.Therefore, a corrective and preventive action (capa) is not necessary at this time.As an action plan, contamination review will be added specifically for all smart tip cannula within the capa review board to determine if adverse trend exists.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 lot met all defined acceptance requirements and was released.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 3ML BLUN TIP VIAL ACCESS COMBO
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11233510
• Report Number: 1017768-2021-00899
• Device Sequence Number: 3805293
• Product Code: FMI
• UDI-Device Identifier: 10884521082977
• UDI-Public: 10884521082977
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: 8881541307
• Device Catalogue Number: 8881541307
• Device Lot Number: 027910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/18/2021
• Patient Sequence Number: 1