BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 7006776 · Received November 7, 2017

    Report

    Report Number
    1213809-2017-00247
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    October 11, 2017
    Report Date
    January 23, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR BATCH 7150658: MANUFACTURING DATE: 06/15/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7150658 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ACCORDING TO THE COMPLAINT DESCRIPTION, THE CUSTOMER MAY BE DESCRIBING CYLINDER IMAGE DOTS THAT ARE PART OF THE PRINTED IMAGE. AN IMAGE MAY HAVE ONE, TWO OR NO DOTS PRINTED NEXT TO THE SCALE MARKINGS. THESE ARE NORMAL AND ARE NOT DEFECTS. HOWEVER, SINCE NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DOTS WERE SEEN ON A BD 10ML SYRINGE LUER-LOK¿ TIP INSIDE THE SEALED PACKAGE BEFORE USE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787687 BD 10ML SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7150658 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other