BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ IV SET S404F W/O BP Y-CONNECTION EV

    MDR report key: 6974883 · Received October 24, 2017

    Report

    Report Number
    2243072-2017-00194
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 17, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND/OR NOT SOLD IN THE US. FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SANXIN FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THIS BEING THE 3RD COMPLAINT FOR AIR LEAKAGE. HOWEVER, NO OTHER IRREGULARITIES OR QUALITY NOTIFICATIONS FOR THE REPORTED LOT NUMBER. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. SANXIN RECHECKED RETENTION SAMPLES FOR SAME LOT: CHECK AIR FILTER WATER RESISTANCE LEVEL FOR SEMI-FINISHED PRODUCT, NO LEAKAGE FOUND. CHECK FINISHED GOOD LOT SIZE 30050PCS, LEAKAGE TEST SAMPLING LEVEL: S-2, AQL1.0 SAMPLE PLAN INSPECTED 13 PCS, NO LEAKAGE FOUND. ROOT CAUSE DESCRIPTION: DURING ULTRASONIC WELDING, THE WELDING MOLD AND AIR VEIN WELDING IS INCOMPLETE BECAUSE THEY ARE NOT KEEPING THE SAME LEVEL OR THE TOOLING DEVICE FOR SPIKE HAVE DEVIATION SO THAT LEAD TO DEVIATION OF AIR FILTER DURING WELDING. THE REASON FOR INCOMPLETE WELDING OR WELDING DEVIATION IS DUE TO FIXTURE TOOLING LOOSEN. CORRECTIVE ACTIONS: MECHANICS ARE REQUIRED TO DO SPOT INSPECTION FOR FIXTURE TOOLING OF SPIKE AND CHAMBER ASSEMBLY MACHINE BEFORE EACH SHIFT TURNOVER TO ENSURE THAT THE FIXTURE TOOLING HAVE NO DEVIATION AND SHAKING. ESTABLISHED A PROCESS CONTROL CHART WHEREBY WHEN IF IT EXCEEDS THE CONTROL LINE, OPERATOR IS REQUIRED TO SHUT DOWN THE EQUIPMENT AND NOTIFY THE MECHANICS TO DEBUG.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF A SYRINGE ON A BD¿ IV SET S404F W/O BP Y-CONNECTION EV WAS FOUND CRACKED AND THE DRUG LEAKED. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750626 BD¿ IV SET S404F W/O BP Y-CONNECTION EV INTERVASCULAR CATHETER FOZ BECTON DICKINSON G1170207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other