BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP

    MDR report key: 7397006 · Received April 4, 2018

    Report

    Report Number
    1213809-2018-00172
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    March 12, 2018
    Report Date
    April 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903050628
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SIX 5ML PACKAGED SYRINGES AND FOUR PHOTOS RECEIVED AT BD CANAAN, CONFIRMED TO BE FROM BATCH # 8011856. SAMPLE WAS VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE MISSING PRINT BETWEEN THE 2ML AND THE 5ML GRADLINES. MISSING PRINT RUN VERTICAL OR THE LONG DIRECTION OF THE BARREL. SAMPLES ARE CONSIDERED REJECTABLE PER PRODUCT SPECIFICATION. BASED ON THE EVALUATION PERFORMED, PRODUCT DEFECT IS CONFIRMED. DHR REVIEW FOR BATCH 8011856: MANUFACTURING DATES: 01/23/2018 TO 01/25/2018. BATCH QUANTITY WAS (B)(4). PRINTING RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8011856 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCALE MARKINGS ON A BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP WERE FOUND FADED MAKING THEM ILLEGIBLE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237847 BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8011856 00382903050628

    Patients

    Seq Age Sex Outcome Treatment
    1 Other