BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32X4 ASIA XTW

    MDR report key: 8401061 · Received March 7, 2019

    Report

    Report Number
    3006948883-2019-00162
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 11, 2019
    Report Date
    February 22, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    UDI-DI
    00382903204779
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED. MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMAL WAS FOUND. CLOG TEST WAS CONDUCTED ON 10PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG FOUND. BASE ON INVESTIGATION, THE COMPLAINT IS NOT MANUFACTURE ISSUE INVESTIGATION CONCLUSION: DHR OF LOT 8123378 WAS REVIEWED AND NO QN FOUND. MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMAL WAS FOUND. PEN NEEDLE PRODUCT HAS 100% CLOG TEST IN FLOWGURU STATION, AND DEFECT PART WILL REJECTED BY FLOWGURU STATION AUTOMATICALLY. CLOG TEST WAS CONDUCTED ON 10PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG FOUND. BASE ON INVESTIGATION ABOVE, THE COMPLAINT IS NOT MANUFACTURE ISSUE. ROOT CAUSE DESCRIPTION: NO RETURNED SAMPLES OR ACTUAL DEFECT SAMPLES FOR INVESTIGATION, SO WE CAN'T PERFORM IN-DEPTH INVESTIGATION. BASED ON THE INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN INSERTING PEN NEEDLES 32X4 ASIA XTW, THERE IS RESISTANCE IN THE PEN AND THE INSULIN IS NOT FLOWING FREELY. SOME INSULIN WILL COLLECT AND SPILL FROM THE POINT OF THE NEEDLE. THE FOLLOWING WAS REPORTED, "I AM WRITING IN RELATION TO A BATCH OF BD ULTRAFINE 0.23 X 4MM NEEDLES. MY DAUGHTER WHO IS A (B)(6) OLD TYPE 1 DIABETIC USES THESE WITH A NOVORAPID PEN TO INJECT INSULIN. WE HAVE USED COUNTLESS NEEDLES AS SHE INJECTS 4 TIMES PER DAY AND WE HAVE JUST COME ACROSS OUR FIRST BATCH OF FAULTY NEEDLES. WHEN INSERTED, THE NEEDLES SEEM TO BE WORKING CORRECTLY, BUT BECAUSE OUR DAUGHTER HAS NOT FULLY PRIMED THE PEN WITH THE NEW NEEDLE, SHE PROCEEDS TO INJECT. THERE IS RESISTANCE IN THE PEN AND SHE REALISES THAT THE INSULIN IS NOT FLOWING FREELY. SOMETIMES SOME INSULIN COMES OUT, SOMETIMES NO INSULIN COMES OUT - IT IS DIFFICULT TO KNOW OR REGULATE. OBVIOUSLY THIS IS VERY DANGEROUS AS WE DO NOT KNOW HOW MUCH INSULIN SHE HAS TAKEN AND WE HAVE TO BE EXTREMELY CAREFUL NOT TO OVERDOSE INSULIN. WHEN THESE ARE FIRST INSERTED SOME INSULIN WILL COLLECT AND SPILL FROM THE POINT OF THE NEEDLE, LEADING ONE TO BELIEVE THAT IT IS WORKING CORRECTLY BUT THEN THE NEEDLE WILL NOT ALLOW MORE INSULIN THROUGH. THERE HAVE BEEN APPROXIMATELY 20 NEEDLES THAT HAVE BEEN FAULTY. OF THE LAST FEW THAT HAVE HAD ISSUES I HAVE KEPT THE SERIAL NUMBERS:"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195206 PEN NEEDLE 32X4 ASIA XTW NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD (SUZHOU) 8123378 00382903204779

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other