BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 7823578 · Received August 28, 2018

    Report

    Report Number
    1911916-2018-00478
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    July 10, 2018
    Report Date
    October 5, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PHOTO WAS PROVIDED TO BD FOR EVALUATION. OUR QUALITY ENGINEER WAS ABLE TO REVIEW THE PROVIDED PHOTO AND DETERMINED THAT THE PHOTO SHOWED A USED NEEDLE ATTACHED TO A SYRINGE. THE ATTACHED NEEDLE AND SYRINGE APPEARED TO BE COVERED WITH WHAT APPEARS TO BE CRYSTALLIZED MEDICATION ON THE EXTERIOR OF THE HUB. THERE APPEARED TO BE NO FIBER PRESENT ON THE SYRINGE IN THE PHOTO. BASED ON THE PROVIDED PHOTO THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO FOREIGN MATTER WAS PRESENT THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE PHOTO. THIS WAS THE SECOND REPORTED CASE OF FOREIGN MATTER ASSOCIATED WITH THIS LOT AND NO CORRECTIVE ACTIONS WERE DEEMED NECESSARY AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THE REPORTED LOT AND NO DEFECTS WERE FOUND DURING PRODUCTION. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PRECISIONGLIDE SPECIALTY USE STERILE HYPODERMIC NEEDLE CONTAINED FOREIGN MATTER DESCRIBED AS "A FIBER ON THE INJECTION NEEDLE". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE CONTAINED FOREIGN MATTER DESCRIBED AS "A FIBER ON THE INJECTION NEEDLE". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666255 BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6363629 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Other