BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 15234139 · Received August 16, 2022

    Report

    Report Number
    9610048-2022-00093
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 21, 2022
    Report Date
    October 26, 2022
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1162045, MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026, DEVICE MANUFACTURE DATE: 08-JUL-2021. MEDICAL DEVICE LOT #: 2063619, MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027, DEVICE MANUFACTURE DATE: 09-MAR-2022. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH A PHOTO OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 1162045 AND 2063619, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED THAT THE DEVICE WAS MISSING THE CATHETER TIP. THEREFORE, BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT THAT OCCURRED DURING THE CATHETER TIPPING PROCESS AND CORRECTIVE MAINTENANCE HAS ALREADY BEEN PERFORMED ON THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ IV CATHETERS DID NOT HAVE A TAPER AT THE END OF THE MATERIAL, RENDERING THEM DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT SHOWS PHOTOGRAPH WHERE INSYTE 20G CATHETER DISTRIBUTED BY SOCOFAR SHOWS A DEFECT IN THE MATERIAL. VIALON CATHETER DOES NOT HAVE A TAPER AT THE END OF THE MATERIAL, EVIDENT MANUFACTURING FAULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ IV CATHETERS DID NOT HAVE A TAPER AT THE END OF THE MATERIAL, RENDERING THEM DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT SHOWS PHOTOGRAPH WHERE INSYTE 20G CATHETER DISTRIBUTED BY SOCOFAR SHOWS A DEFECT IN THE MATERIAL. VIALON CATHETER DOES NOT HAVE A TAPER AT THE END OF THE MATERIAL, EVIDENT MANUFACTURING FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288316 BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown