BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7212523 · Received January 23, 2018

    Report

    Report Number
    1911916-2018-00006
    Event Type
    Malfunction
    Date Received
    January 23, 2018
    Date of Event
    January 2, 2018
    Report Date
    February 27, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051961
    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: QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. DHR REVIEW: ASSEMBLY BATCH 7060534 HAD (B)(4) VISUAL INSPECTIONS PERFORMED ON (B)(4) PARTS WITH ONE DEFECT NOTED FOR INSUFFICIENT EPOXY. ALL AFFECTED PRODUCT WAS SCRAPPED IN-PROCESS. INVESTIGATION RESULTS: NOT APPLICABLE; NO SAMPLE OR PHOTO WERE PROVIDED. BASED ON THE DESCRIPTION, THE FM IS PROBABLY AN EPOXY SPLATTER ON THE CANNULA. POSSIBLE ROOT CAUSE: PROBABLE ROOT CAUSES: THE RACK OF NEEDLES FELL AGAINST ANOTHER RACK COMING IN CONTACT WITH UNCURED EPOXY. (MOST LIKELY IN VIEW OF THE NOTE IN THE DHR REGARDING A ROLL UP.) A MISASSEMBLED NEEDLE WITH UNCURED EPOXY CAME INTO CONTACT WITH THE NEEDLES IN QUESTION DURING ASSEMBLY. EPOXY CONTAMINATED THE CATERPILLAR BELTS ON THE ASSEMBLY LINE AND TRANSFERRED TO THE CANNULA.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BEFORE USE A BD PRECISIONGLIDE¿ NEEDLE WAS FOUND WITH ¿A WHITE SPOT ON THE NEEDLE WHEN OPENED IN THE CACI. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55211 BD PRECISIONGLIDE¿ NEEDLE SAFETY ENGINEERED NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 7086929 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 Other