BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7648723 · Received June 28, 2018

    Report

    Report Number
    8041187-2018-00211
    Event Type
    Malfunction
    Date Received
    June 28, 2018
    Date of Event
    June 5, 2018
    Report Date
    July 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO PHOTOS WERE RETURNED FOR INVESTIGATION. A DENTED MARK ON SYRINGE BARREL WAS OBSERVED FROM PHOTO RETURNED FOR INVESTIGATION. THREE ACTUAL SAMPLES RETURNED FOR INVESTIGATION AND OBSERVED DENT ON SYRINGE BARREL. ACTUAL SAMPLE WAS SUBJECTED TO LEAK TEST AND OBSERVED NO LEAK FROM THE DENTED MARK. DHR REVIEW SHOWED NO ABNORMALITY DURING PRODUCTION THAT COULD INFLUENCE THE REPORTED DEFECT. THE DENTED BARREL COULD BE DUE TO A PART THAT GOT JAMMED AT THE OUT-FEED DIAL AT THE ASSEMBLY MACHINE. THE JAMMED PARTS MAY HAVE NOT BEEN PROPERLY CLEARED BY THE PRODUCTION TECHNICIAN WHICH RESULTED ESCAPEES TO THE DOWNSTREAM PROCESS. ON-JOB TRAINING BLUEPRINT WAS INITIATED TO INCLUDE VERIFICATION THAT NO DAMAGED PARTS FLOW TO THE OUTFEED AFTER AUTO-REJECT STATION AND REMOVE ALL DAMAGED PARTS IF DETECTED. THE OJT TRAINING WAS CONDUCTED AND RELEASED IN AUGUST 2017. A SENSOR TO DETECT PARTS JAM AT OUTFEED RAIL HAD BEEN INSTALLED IN SEPTEMBER 2017. THIS BATCH IS PRODUCED BEFORE THE CORRECTIVE ACTION. THE TEAM WILL CONTINUE TO MONITOR FOR ANY RE-OCCURRENCES. CORRECTIVE ACTION IMPLEMENTED AND AFFECTED BATCH IS PRODUCED BEFORE THE CORRECTIVE ACTION. CONTINUE TO MONITOR THE NONCONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE A BD SYRINGE LUER-LOK¿ TIP WAS FOUND LEAKING AS " DEFEAT OF LEAKAGE ON THE BARREL OF SYRINGE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 DURING USE A BD SYRINGE LUER-LOK¿ TIP WAS FOUND LEAKING AS " DEFEAT OF LEAKAGE ON THE BARREL OF SYRINGE." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488497 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 7172062

    Patients

    Seq Age Sex Outcome Treatment
    1 Other