BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE LUER SLIP

    MDR report key: 7059476 · Received November 27, 2017

    Report

    Report Number
    3002682307-2017-00101
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 23, 2017
    Report Date
    December 12, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: EVALUATION OF MAINTENANCE, QUALITY NOTIFICATION AND BATCH HISTORY WAS ANALYZED FOR CATALOGUE 990581, LOT # 7053936. THERE ARE NO COMPLAINTS FOR THE SAME DEFECT, NOR OCCURENCES OR QUALITY NOTIFICATIONS IN THIS BATCH. DUE TO NO SAMPLES OR PHOTOS, UNABLE TO INVESTIGATE AND RESEARCH THE COMPLAINT. THE ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE FAILURE MODE INDICATED BY THE CUSTOMER. 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. INVESTIGATION CONCLUSION: EVALUATION OF MAINTENANCE, QUALITY NOTIFICATION AND BATCH HISTORY WAS ANALYZED FOR CATALOGUE 990581, LOT # 7053936. THERE ARE NO COMPLAINTS FOR THE SAME DEFECT, NOR OCCURENCES OR QUALITY NOTIFICATIONS IN THIS BATCH. DUE TO NO SAMPLES OR PHOTOS,UNABLE TO INVESTIGATE AND RESEARCH THE COMPLAINT. THE ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE FAILURE MODE INDICATED BY THE CUSTOMER. ROOT CAUSE DESCRIPTION: PROBABLE CAUSES: WITHOUT SAMPLES OR PHOTOS IT WAS NOT POSSIBLE DETERMINE THE ROOT CAUSE FOR THIS DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PLASTIPAK¿ SYRINGE LUER SLIP PRODUCT WAS FOUND LEAKING DURING USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839010 BD PLASTIPAK¿ SYRINGE LUER SLIP SYRINGE FMF BECTON DICKINSON, S.A. 7053936

    Patients

    Seq Age Sex Outcome Treatment
    1 Death