BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8705254 · Received June 17, 2019

    Report

    Report Number
    1911916-2019-00591
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 31, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051954
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLES ARE COMING OUT OF THE HUB WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305195 BATCH NO: 7361738 AND 6152995. IT WAS REPORTED THAT NEEDLES ARE BENDING/BREAKING AT THE HUB. SHE SAID THE NEEDLES ARE BENDING/BREAKING WHERE THE NEEDLE ATTACHES TO THE HUB. IT OCCURRED APPROXIMATELY 6 TIMES OVER THE 2 BOXES (EACH BOX IS A DIFFERENT LOT #).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7361738, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30, DEVICE MANUFACTURE DATE: 2017-12-27. MEDICAL DEVICE LOT #: 6152995, MEDICAL DEVICE EXPIRATION DATE: 2021-07-31, DEVICE MANUFACTURE DATE: 2021-07-31. " DEVICE EVALUATED BY MFR: 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 NEEDLES ARE COMING OUT OF THE HUB WITH BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305195, BATCH NO: 7361738 AND 6152995. IT WAS REPORTED THAT NEEDLES ARE BENDING/BREAKING AT THE HUB. SHE SAID THE NEEDLES ARE BENDING/BREAKING WHERE THE NEEDLE ATTACHES TO THE HUB. IT OCCURRED APPROXIMATELY 6 TIMES OVER THE 2 BOXES (EACH BOX IS A DIFFERENT LOT #).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497087 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903051954

    Patients

    Seq Age Sex Outcome Treatment
    1 Other