BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

    MDR report key: 6815003 · Received August 23, 2017

    Report

    Report Number
    1213809-2017-00089
    Event Type
    Malfunction
    Date Received
    August 23, 2017
    Date of Event
    July 10, 2017
    Report Date
    November 9, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (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: DHR REVIEW FOR BATCH 7060629 (P/N (B)(4)): MANUFACTURING DATES: 03/22/2017 ¿ 03/23/2017. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7060629 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE OPENED 3ML PACKAGED SYRINGE WAS RECEIVED BY BD CANAAN AND REPORTED TO BE FROM BATCH #7060629 (P/N (B)(4)). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE SEVERE SKEWED SCALE. THE SEVERE SKEW CAUSED MISSING PRINT ON THE BARREL. SKEWED SCALE IS CAUSED WHEN THE BARREL AND THE PRINT CYLINDER ARE NOT PROPERLY ALIGNED DURING THE PRINTING PROCESS. BASED ON THE SAMPLE EVALUATION: CONFIRMED: BD (B)(4) 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ WAS FOUND MISSING GRADUATION PRINTING. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594653 BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7060629

    Patients

    Seq Age Sex Outcome Treatment
    1 Other