BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 6765863 · Received August 3, 2017

    Report

    Report Number
    1213809-2017-00055
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Date of Event
    July 10, 2017
    Report Date
    September 19, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DHR REVIEW FOR BATCH 7060632 (P/N 309657): MANUFACTURING DATES: 3/17/2017 ¿ 3/18/2017. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7060632 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE 3 ML SAMPLE IN ITS ORIGINAL SEALED PACKAGE WAS RECEIVED BY BD CANAAN AND CONFIRMED TO BE FROM BATCH #7060632 (P/N 309657). VISUAL INSPECTION REVEALED AN OILY SUBSTANCE INSIDE THE PACKAGE COVERING THE BARREL. THE SUBSTANCE SEEPED THROUGH THE TOP WEB IN SPOTS. THE PRINT ON THE SYRINGE WAS SPOTTY AND MOSTLY ABSENT. BASED ON THE SAMPLE EVALUATION: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE: HYDRAULIC OIL FROM A MOLDING PRESS. THE OIL PREVENTED THE PRINT FROM ADHERING TO THE BARREL. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A YELLOWISH BROWN SUBSTANCE OR STAINING WAS FOUND IN A 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP SYRINGE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543108 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP CONVENTIONAL SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7060632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other