BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 7130241 · Received December 19, 2017

    Report

    Report Number
    1213809-2017-00363
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 29, 2017
    Report Date
    February 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: SAMPLE EVALUATION: TWO PHOTOS WERE RECEIVED BY BD CANAAN AND EVALUATED. THE PRODUCT IN THE PHOTO IS A SINGLE PACKAGED 3ML SYRINGE CONFIRMED TO BE FROM BATCH #7122982 (P/N 309657). THE SAMPLE HAS MISSING PRINT AT VARIOUS POINTS THROUGHOUT THE BARREL. THE TIP OF THE BARREL WAS NOT SHOWN IN THE PHOTOS THEREFORE COULD NOT BE EVALUATED. THE FLANGE APPEARS TO SHOW SIGNS OF DISCOLORATION, HOWEVER DUE TO LOW PHOTO RESOLUTION QUALITY, IT COULD NOT BE EVALUATED IN GREATER DETAIL TO BE CONFIRMED. DHR REVIEW FOR BATCH 7122982 (P/N 309657): MANUFACTURING DATES: 05/24/2017 TO 05/25/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7122982 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. 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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PRINTING DEFECT ON THE ¿NUMBERS¿ AND FOREIGN MATTER FOUND ON THE TIP OF THE 3 ML BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911717 BD LUER-LOK¿ DISPOSABLE SYRINGE WITH LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7122982 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other