BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 60ML LL BRAZIL

    MDR report key: 8851611 · Received August 1, 2019

    Report

    Report Number
    1911916-2019-00760
    Event Type
    Malfunction
    Date Received
    August 1, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 22, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. INVESTIGATION CONCLUSION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SCALE MARKING ISSUE FOR LOT #8155574 ITEM #302827. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS. RATIONALE: NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE MISSING VOLUMETRIC MARKINGS WITH A BD SYRINGE 60ML LL (B)(6), THIS WAS DISCOVERED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE WITH ABSENCE OF MICROMETRIC VOLUMETRIC MARKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645806 BD SYRINGE 60ML LL BRAZIL PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 8155574

    Patients

    Seq Age Sex Outcome Treatment
    1 Other