BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILLINOIS (TJ) NEEDLE ASPIRATION 15GA

    MDR report key: 9271987 · Received November 4, 2019

    Report

    Report Number
    1625685-2019-00125
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 15, 2019
    Report Date
    December 11, 2019
    Manufacturer
    CAREFUSION, INC
    Product Code
    LWE
    PMA / PMN Number
    K913306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PR 1230577 FOLLOW UP EMDR FOR DEVICE EVALUATION. ONE SAMPLE WAS RECEIVED FOR EVALUATION. SAMPLE EVALUATION CONFIRMED THE REPORTED FAILURE MODE (LOOSE). THE NEEDLE PROTECTOR WAS FOUND DETACHED FROM THE NEEDLE AND LOOSE IN THE PACKAGING. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THAT ALL INSPECTION RESULTS PASSED PER THE DEVICE HISTORY RECORD REVIEW PROCESS AND NO ANOMALIES WERE NOTICED DURING PRODUCTION. THE MOST PROBABLE ROOT CAUSE WAS IDENTIFIED AS A MANUFACTURING ASSEMBLY ERROR DURING THE PLACEMENT OF THE NEEDLE PROTECTOR ONTO THE NEEDLE ASSEMBLY. BASED ON THE IDENTIFIED PROBABLE ROOT CAUSE, ALL APPLICABLE MANUFACTURING PERSONNEL WILL BE NOTIFIED OF THIS COMPLAINT AND PROVIDED WITH THE PROPER ASSEMBLY PROCESS TO ENSURE THE NEEDLE PROTECTOR IS PROPERLY MATED TO THE NEEDLE ASSEMBLY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    WHILE THE PHYSICIAN OPENING THE POUCH, HE FOUND THE NEEDLE¿S PROTECTOR WAS DISCONNECTED FROM THE NEEDLE, AND THE POUCH HAD BEEN PUNCTURED BY THE NEEDLE. THE PHYSICIAN THOUGHT ITS STERILE BARRIER SHOULD HAVE BEEN BROKEN, SO HE DARED NOT TO USE AND RETURNED THE NEEDLE TO US. THE REPORTABLE EVENT IS THE STERILE BREACH.

    Additional Manufacturer Narrative · 1

    (B)(4): DATE OF EVENT NOT PROVIDED, USED AWARE DATE. (B)(4). IF FURTHER INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WHILE THE PHYSICIAN OPENING THE POUCH, HE FOUND THE NEEDLE¿S PROTECTOR WAS DISCONNECTED FROM THE NEEDLE, AND THE POUCH HAD BEEN PUNCTURED BY THE NEEDLE. THE PHYSICIAN THOUGHT ITS STERILE BARRIER SHOULD HAVE BEEN BROKEN, SO HE DARED NOT TO USE AND RETURNED THE NEEDLE TO US. THE REPORTABLE EVENT IS THE STERILE BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065272 ILLINOIS (TJ) NEEDLE ASPIRATION 15GA BONE MARROW COLLECTION/TRANSFUSION KIT LWE CAREFUSION, INC 1213059

    Patients

    Seq Age Sex Outcome Treatment
    1 Other