BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 25G X 1 1/2 IN

    MDR report key: 10558214 · Received September 20, 2020

    Report

    Report Number
    1911916-2020-00877
    Event Type
    Malfunction
    Date Received
    September 20, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 3, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0022044. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. THE CAUSE OF THIS DEFECT COULD HAVE HAPPENED THAT WHILE PASSING THE NEEDLE THROUGH THE STOPPER VIAL THE NEEDLE GOT CLOGGED WITH THE STOPPER VIAL MATERIAL. DURING THE MANUFACTURING PROCESS A VISION SYSTEM IS INSPECTING 100% ALL THE PRODUCTS FOR CLOGGED NEEDLES. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD PRECISIONGLIDE¿ NEEDLES 25 G X 1 1/2 IN EXPERIENCED CLOGGED/BLOCKED NEEDLES. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305127, BATCH NO: 0022044. REPORTED ISSUE: NOT ABLE TO SQUIRT THE CONTENTS OUT OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022823 BD PRECISIONGLIDE NEEDLE 25G X 1 1/2 IN PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 305127 0022044 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 Other