BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP

    MDR report key: 7426003 · Received April 12, 2018

    Report

    Report Number
    1213809-2018-00216
    Event Type
    Malfunction
    Date Received
    April 12, 2018
    Date of Event
    March 28, 2018
    Report Date
    April 18, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903050629
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    3 SEALED 5ML LUER-LOK SYRINGES AND TWO PHOTOS WERE RECEIVED, CONFIRMED TO BE FROM BATCH # 8011856 (P/N 305062). SAMPLES WERE VISUALLY EVALUATED. ALL 3 SAMPLES WERE FOUND TO HAVE MISSING PRINT BETWEEN 2ML AND THE BD LOGO. THE MISSING PRINT WAS MORE THAN 50% OF ANY ONE ITEM, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. DHR REVIEW FOR BATCH 8011856 (P/N 305062): 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. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION.

    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 THE MEASURE MARKINGS ON A BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP WERE ¿INCOMPLETE¿, AND MISSING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266920 BD PLASTIPAK¿ SYRINGE WITH LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8011856 30382903050629

    Patients

    Seq Age Sex Outcome Treatment
    1 Other