BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 12675219 · Received October 21, 2021

    Report

    Report Number
    1911916-2021-01099
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 23, 2021
    Report Date
    October 4, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TO AID IN THE INVESTIGATION, ONE SAMPLE WITH THE PLASTIC SHIELD IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST WITH A 10X MAGNIFIER LENS, AND THEN WITH A 30X MICROSCOPE. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. THE SOLUTION EXPELLED WITH NORMAL FLOW. NO LEAKAGE WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305109, LOT NUMBER 0072080. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD PRECISIONGLIDE¿ NEEDLE, THE DEVICE EXPERIENCED A DAMAGED/ BROKEN/ SPLIT NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED:   IT WAS REPORTED BY THE CONSUMER, THERE IS A SPLIT/BREAK IN THE BASE OF THE NEEDLE HUB AND THE MEDICATION LEAKED THROUGH THE SPLIT. CONSUMER REPORTED THAT THERE IS A SPLIT (BREAK) IN THE BASE OF THE NEEDLE HUB.CONSUMER ALSO REPORTED THAT THE MEDICATION LEAKED THROUGH THE HUB AS A RESULT OF THE SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1575381 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305109 0072080 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1