BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 11426789 · Received March 7, 2021

    Report

    Report Number
    1911916-2021-00185
    Event Type
    Malfunction
    Date Received
    March 7, 2021
    Date of Event
    February 8, 2021
    Report Date
    February 26, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305197 AND LOT NUMBER 0143226. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED DEFECT. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS FOUR PACKAGING BLISTERS WITH THE NEEDLE ASSEMBLY AND BOTTOM WEB. THE OTHER PHOTO SHOWS THE PACKAGING BLISTER TOP WEB. THE TOP WEB IS ACCORDING TO THE PRODUCT SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, THE PHOTOS RECEIVED DID NOT SHOW THE SYMPTOM REPORTED BY THE CUSTOMER AND AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 BD PRECISIONGLIDE¿ NEEDLES WERE MISSING THE HEALTH REGISTRATION MARKING ON THEIR LABELS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WE HAVE EVIDENCED 4 NEEDLES WITHOUT HEALTH REGISTRATION MARKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323398 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305197 0143226 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1