BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRONTO QUICK RELEASE HOLDER

    MDR report key: 7058827 · Received November 27, 2017

    Report

    Report Number
    2243072-2017-00249
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    April 28, 2016
    Report Date
    November 1, 2017
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT UNKNOWN: DATE OF NOTIFICATION HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). RESULTS: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. CUSTOMER SAMPLES WERE RECEIVED FOR BATCHES 5203971, AND 6020623. NO SAMPLES WERE RECEIVED FROM BATCH 6020623. ALL SAMPLES WERE VISUALLY INSPECTED FOR PIERCED SLEEVE AND FUNCTIONALLY EVALUATED FOR SLEEVE LEAKAGE. THERE WERE NO SLEEVE LEAKAGE OR SIDE PIERCE DEFECTS IDENTIFIED. THIS COMPLAINT WAS CHECKED WITH BATCHES: 5203971, 6020623, AND 5252587.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE INSIDE THE BD PRONTO QUICK RELEASE HOLDER + NEEDLE CAME LOOSE FROM THE HOLDER DURING USE. ECLIPSE USED IN COMBINATION WITH PRONTO HOLDER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841133 BD PRONTO QUICK RELEASE HOLDER HOLDER JKA BECTON DICKINSON 14M24

    Patients

    Seq Age Sex Outcome Treatment
    1 Other