BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 10988929 · Received December 10, 2020

    Report

    Report Number
    1911916-2020-01107
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 12, 2020
    Report Date
    November 24, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051106
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305110 AND LOT NUMBER 9212458. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, ONE PHOTO SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLY WITH NO PLASTIC SHIELD AND THE PACKAGING BLISTER TOP WEB. THE NEEDLE ASSEMBLY HAS A DOUBLE NEEDLE ATTACHED TO THE NEEDLE HUB WITH THE WHITE EPOXY. IT COULD BE POSSIBLE FOR THIS DEFECT TO OCCUR DURING THE ASSEMBLY PROCESS. THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB WITH WHITE EPOXY TO FIX IT. IN THIS CASE, A MISFEED MAY HAVE INDUCED A DOUBLE NEEDLE AND EPOXY ON THE NEEDLE HUB. BASED ON THE INVESTIGATION WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE. NIP ASSEMBLY LINE. THE PLASTIC HUB IS PLACED UNDER THE CANNULATOR THEN THE NEEDLE IS POSITIONED AND ASSEMBLED TO THE PLASTIC HUB ADDING THE WHITE EPOXY TO FIX IT; AFTER THAT, A PLASTIC SHIELD IS ASSEMBLED. IN THIS CASE, THE MISFEEDING OF THE CANNULATOR MAY HAVE INDUCED TO HAVE THE DOUBLE NEEDLE AND THE EPOXY ON THE NEEDLE HUB.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED THE NEEDLE POINT PENETRATING THROUGH THE SHIELD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PART OF THE PRECISION GLIDE NEEDLE HAS BROKEN OFF AND HAS PRESSED INTO/PIERCED THE ORANGE CAP MAKING IT UNUSABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446967 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 9212458 00382903051106

    Patients

    Seq Age Sex Outcome Treatment
    1