BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE INTEGRA 25X1 RB TW

    MDR report key: 11457621 · Received March 10, 2021

    Report

    Report Number
    1911916-2021-00197
    Event Type
    Malfunction
    Date Received
    March 10, 2021
    Date of Event
    February 10, 2021
    Report Date
    March 4, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903053118
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE INTEGRA 25X1 RB TW WERE DAMAGED/DEFECTED. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCING SOME MALFUNCTION WITH INTEGRA NEEDLES.  VERBATIM:...A NURSE FOR SUTTER HEALTH INTERNAL MEDICINE DEPARTMENT. I JUST WANT TO REPORT SOME MALFUNCTION BD INTEGRA NEEDLES. BELOW IS THE BRAND NAME AND BADGE OR REFERENCE NUMBER. BD INTEGRA RETRACTING NEEDLE REF: 305311."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353226 NEEDLE INTEGRA 25X1 RB TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305311 UNKNOWN 30382903053118

    Patients

    Seq Age Sex Outcome Treatment
    1