BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEOFLON IV CANNULA

    MDR report key: 10171952 · Received June 18, 2020

    Report

    Report Number
    8041187-2020-00348
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    May 28, 2020
    Report Date
    July 2, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEOFLON¿ IV CANNULAS EXPERIENCED CATHETERS BACKING OUT OF THE VEIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSES COMPLAIN THAT: -THE WINGS ARE TOO SMALL TO BE FIXED AND IT IS HARD TO REMOVE THEIR CLIP -THE CATHETER NEEDS GREAT EFFORT TO INSERT INTO THE SKIN AND TEARS UP THE VEIN WHILE INSERTION. -THE CATHETER GETS OUT EASILY WHILE WORKING WITH AND THEY HAVE TO CHANGE IT 4-5 TIMES A DAY IN SOME CASES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9040675. MEDICAL DEVICE EXPIRATION DATE: 2024-01-31. DEVICE MANUFACTURE DATE: 2019-02-09. MEDICAL DEVICE LOT #: 9144966. MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. DEVICE MANUFACTURE DATE: 2019-05-24.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEOFLON¿ IV CANNULAS EXPERIENCED CATHETERS BACKING OUT OF THE VEIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NURSES COMPLAIN THAT: THE WINGS ARE TOO SMALL TO BE FIXED AND IT IS HARD TO REMOVE THEIR CLIP. THE CATHETER NEEDS GREAT EFFORT TO INSERT INTO THE SKIN AND TEARS UP THE VEIN WHILE INSERTION. THE CATHETER GETS OUT EASILY WHILE WORKING WITH AND THEY HAVE TO CHANGE IT 4-5 TIMES A DAY IN SOME CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635828 BD NEOFLON IV CANNULA INTERVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other