BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INFUSION SYSTEM ADAPTOR

    MDR report key: 7981974 · Received October 18, 2018

    Report

    Report Number
    3003152976-2018-00454
    Event Type
    Malfunction
    Date Received
    October 18, 2018
    Date of Event
    September 17, 2018
    Report Date
    October 25, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    K123213
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PICTURE SAMPLE FOR LOT NUMBER K71649-1 WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING THE PRODUCTION OF LOT NUMBER K71649-1 THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THROUGH VISUAL INSPECTION OF THE RETURNED PICTURE, THE PRODUCT TUBING WAS OBSERVED WITHOUT THE CLAMP COMPONENT. WITHIN THE BD FACILITY, THE CONNECTOR COMPONENT IS MOLDED AND THE MEMBRANE IS ASSEMBLED. THE REST OF THE PRODUCT COMPONENTS INCLUDING THE TUBING AND THE CLAMP, ARE RECEIVED FROM A SUPPLIER LOCATION AND THE FINAL ASSEMBLY OF THE PRODUCT IS ALSO PERFORMED AT THE SUPPLIER LOCATION. THIS INCIDENT WAS REPORTED TO THE SUPPLIER COMPANY FOR INVESTIGATION. THE SUPPLIER REPORTED THAT THE MISSING COMPONENT WAS A RESULT OF HUMAN ERROR, AS THE CLAMP IS ASSEMBLED MANUALLY. A CHANGE IS CURRENTLY UNDERWAY FOR THE MANUFACTURING SITES OF THIS PRODUCT, THEREFORE, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. DHR: NO NON-CONFORMANCES FOUND. ONE COMPLAINT WAS SENT TO CODAN (B)(4). ACCORDING TO THE REPORT RECEIVED, THE ROOT CAUSE OF THE DEFECT WAS A HUMAN MISTAKE, AS THE CLAMP ASSEMBLY IS MANUAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PHASEAL INFUSION SYSTEM ADAPTOR THE CLAMP WAS MISSING ON THE TUBING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD PHASEAL¿ INFUSION SYSTEM ADAPTOR THE CLAMP WAS MISSING ON THE TUBING. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817317 BD PHASEAL¿ INFUSION SYSTEM ADAPTOR INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. K71649-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other