BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 13577912 · Received February 22, 2022

    Report

    Report Number
    8041187-2022-00094
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    January 17, 2022
    Report Date
    February 22, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE FIRST PHOTO, IT WAS OBSERVED THAT A NEEDLE CAP AND TETHER FOIL DETACHED FROM THE NEEDLE HUB AND REMAINED ATTACHED TO THE CANNULA HUB ON A PATIENT¿S ARM. NO DAMAGE WAS OBSERVED ON THE TETHER HOLE AND NO PHENOMENON OF STRETCHED IS OBSERVED ON THE TETHER. THE SECOND PHOTO SHOWS A TORN TOP WEB OF BATCH 1203069. THE THIRD AND FOURTH PHOTOS SHOW AN EXPOSED NEEDLE WITHOUT THE TETHER FOIL AND NEEDLE CAP AND AN EXPOSED NEEDLE DETACHED FROM THE TETHER FOIL AND NEEDLE CAP, RESPECTIVELY. 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 PHOTO RETURNED, THE PROBABLE ROOT CAUSE COULD BE DUE TO THE HEAT STAKE POST NOT WIDE ENOUGH TO PREVENT THE TETHER FOIL FROM GETTING LOOSE. THE MANUFACTURING PROCESS HAS BEEN REVIEWED. THERE IS A VISION SYSTEM TO DETECT THE PRESENCE OF THE TETHER FOIL AND THE DIAMETER OF THE HEAT STAKE POST. IF THE TETHER FOIL WAS NOT FIT PROPERLY ONTO THE HEAT STAKE POST, OR THE HEAT STAKE DIAMETER DOES NOT MEET THE REQUIREMENT, THE MACHINE WILL REJECT THE PART. AS THE ACTUAL SAMPLE WAS NOT RETURNED, FURTHER INVESTIGATION CANNOT BE PERFORMED. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: H.6. EVENT PROBLEM AND EVALUATION CODES: A CODE HAS CHANGED FROM A1501 TO A0501. H.6. INVESTIGATION SUMMARY: FOUR PHOTOS WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE FIRST PHOTO, IT WAS OBSERVED THAT A NEEDLE CAP AND TETHER FOIL DETACHED FROM THE NEEDLE HUB AND REMAINED ATTACHED TO THE CANNULA HUB ON A PATIENT¿S ARM. NO DAMAGE WAS OBSERVED ON THE TETHER HOLE AND NO PHENOMENON OF STRETCHED IS OBSERVED ON THE TETHER. THE SECOND PHOTO SHOWS A TORN TOP WEB OF BATCH 1203069. THE THIRD AND FOURTH PHOTOS SHOW AN EXPOSED NEEDLE WITHOUT THE TETHER FOIL AND NEEDLE CAP AND AN EXPOSED NEEDLE DETACHED FROM THE TETHER FOIL AND NEEDLE CAP, RESPECTIVELY. 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 PHOTO RETURNED, THE PROBABLE ROOT CAUSE COULD BE DUE TO THE HEAT STAKE POST NOT WIDE ENOUGH TO PREVENT THE TETHER FOIL FROM GETTING LOOSE. THE MANUFACTURING PROCESS HAS BEEN REVIEWED. THERE IS A VISION SYSTEM TO DETECT THE PRESENCE OF THE TETHER FOIL AND THE DIAMETER OF THE HEAT STAKE POST. IF THE TETHER FOIL WAS NOT FIT PROPERLY ONTO THE HEAT STAKE POST, OR THE HEAT STAKE DIAMETER DOES NOT MEET THE REQUIREMENT, THE MACHINE WILL REJECT THE PART. AS THE ACTUAL SAMPLE WAS NOT RETURNED, FURTHER INVESTIGATION CANNOT BE PERFORMED. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM FAILED ON THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTING THE CATHETER AND WITHDRAWAL OF THE STEEL NEEDLE THE SAFETY PROTECTOR DID NOT WORK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SAFETY MECHANISM FAILED ON THE BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTING THE CATHETER AND WITHDRAWAL OF THE STEEL NEEDLE THE SAFETY PROTECTOR DID NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685127 BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 1203069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown