BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7451303 · Received April 23, 2018

    Report

    Report Number
    1911916-2018-00183
    Event Type
    Malfunction
    Date Received
    April 23, 2018
    Date of Event
    February 21, 2018
    Report Date
    April 20, 2018
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051106
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO THE MANUFACTURING PLANT FOR EVALUATION. A QUALITY ENGINEER INSPECTED THE SAMPLE AND FOUND THAT THERE WAS A 19GA. 1" NEEDLE PACKAGED WITH THE 26GA 3/8" NEEDLES THUS VERIFYING THE REPORTED ISSUE. MIX-UPS CAN HAPPEN IF THERE WAS AN ISSUE WITH LINE CLEARANCE AFTER A LOT WAS PRODUCED. A DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND FOUND ZERO DEFECTS NOTED FOR MIXED PRODUCT DURING PRODUCTION. INVESTIGATION CONCLUSION: QN REVIEW: NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH. DHR REVIEW: FIFTEEN VISUAL INSPECTIONS WERE PERFORMED ON 900 PARTS WITH ZERO DEFECTS NOTED FOR MIXED PRODUCT. THE BATCH PACKAGED PRIOR TO THIS ONE WAS T19 X 1 SB. INVESTIGATION RESULTS: ONE SAMPLE WAS RETURNED. THERE IS A 19 GA. 1" NEEDLE PACKAGED WITH THE 26 GA. 3/8" NEEDLES. ROOT CAUSE DESCRIPTION: IMPROPER LINE CLEARANCE. RATIONALE: THE AQL FOR MIXED PRODUCT IS (B)(4). THE SIZE OF THIS BATCH WAS (B)(4). ONE INCORRECT NEEDLE IS A DEFECT RATE OF (B)(4). SINCE THE AQL IS NOT EXCEEDED, NO CAPA WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PRECISIONGLIDE¿ NEEDLE WAS MIXED IN THE INSIDE PACKING. FOUND BEFORE USE. NO OTHER SPECIFICS GIVEN. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292749 BD PRECISIONGLIDE¿ NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 6179848 00382903051106

    Patients

    Seq Age Sex Outcome Treatment
    1 Other