BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE - EJM4011

    MDR report key: 12804133 · Received November 12, 2021

    Report

    Report Number
    1625685-2021-00089
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    June 15, 2021
    Report Date
    March 22, 2022
    Manufacturer
    CAREFUSION, INC
    Product Code
    KNW
    UDI-DI
    10885403464157
    PMA / PMN Number
    K171531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW-UP EMDR FOR DEVICE EVALUATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001327171 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER HERE.

    Additional Manufacturer Narrative · 0

    PR 3883280 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: (B)(4). PATIENT PROBLEM CODE:(B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. VERBATIM: IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES DESCRIBE THE EVENT OR PROBLEM: IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. MANUFACTURER RESPONSE FOR BONE MARROW BIOPSY NEEDLE, (BRAND NOT PROVIDED) (PER SITE REPORTER) : NONE YET. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : BONE MARROW BIOPSY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. VERBATIM: IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. DESCRIBE THE EVENT OR PROBLEM: IT WAS REPORTED THAT THE INNER MEASURING STICK DID NOT HAVE MEASUREMENT LINES. MANUFACTURER RESPONSE FOR BONE MARROW BIOPSY NEEDLE, (BRAND NOT PROVIDED) (PER SITE REPORTER) : NONE YET. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : BONE MARROW BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703345 JAMSHIDI (EJ) NEEDLE BM 11GX4 CRADLE - EJM4011 INSTRUMENT, BIOPSY KNW CAREFUSION, INC EJM4011 0001327171 10885403464157

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other