BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11697805 · Received April 20, 2021

    Report

    Report Number
    1911916-2021-00347
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 12, 2021
    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
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED THE NEEDLE PUNCTURED THROUGH THE SHIELD DURING RECAPPING. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS AN OPENED PACKAGING BLISTER AND NEEDLE ASSEMBLY WITH THE PLASTIC SHIELD. THIS IS TO SHOW THE PRODUCT AND IS NOT THE ACTUAL PRODUCT WITH THE SYMPTOM REPORTED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT NUMBER 9240783. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. BASED ON THE INVESTIGATION WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. THIS DEFECT CAN OCCUR IF THE PRODUCT IS NOT USE AS INTENDED. THE CUSTOMER ACKNOWLEDGED THAT SCRUB TECHS USE A ONE HANDED SCOOP METHOD TO RECAP THE NEEDLES. THESE PRODUCTS SHOULD NOT BE RECAPPED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PRECISIONGLIDE¿ NEEDLES CAUSED NEEDLE STICK INJURIES DUE TO PIERCING THROUGH THEIR SHIELD WHILE RECAPPING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE HAS BEEN TWO NEEDLE STICKS USING THE 30 GUAGE NEEDLE, 305106. THE SCRUB TECHS DO THE ONE HANDED SCOOP METHOD TO RECAP THE NEEDLE. THESE NEEDLES ARE USED SEVERAL TIMES FOR ADMINISTERING LOCAL ON THE STERILE FIELD. IN BOTH SITUATIONS, THE NEEDLE PUNCTURED THROUGH THE CAP. WHEN THE TECHS WENT TO REMOVE THE CAP, THEY GOT STUCK. THEY CURRENTLY ORDERED ANOTHER BRAND OF 30 GUAGE NEEDLES TO SEE IF THE CAP WAS MORE DURABLE. THIS DOES NOT HAPPEN WITH THE OTHER SIZES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589721 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305106 9240783 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention