BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-SLIP SYRINGE

    MDR report key: 7541273 · Received May 24, 2018

    Report

    Report Number
    3003152976-2018-00226
    Event Type
    Malfunction
    Date Received
    May 24, 2018
    Date of Event
    May 21, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INVESTIGATION: THROUGH EXAMINATION OF THE PICTURE SAMPLE PROVIDED, OUR QUALITY ENGINEER OBSERVED THE SCALE TO BE PARTIALLY MISSING FROM THE SYRINGE; THE MARKINGS ONLY WENT UP TO 8ML. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED LOT NUMBER REVEALED ONE RELATED ANNOTATION DURING PRODUCTION. DURING THE MANUFACTURING PROCESS, A FAILURE WAS DETECTED IN THE MARKING MACHINE, WHICH CAUSED MISSING AND DEFECTIVE SCALE MARKINGS. ONCE THE FAILURE WAS DETECTED, DEFECTIVE PRODUCT WAS REJECTED AND THE MECHANICAL TEAM REPAIRED THE FAILURE. AS THE OBSERVED/REPORTED DEFECT COINCIDES WITH THE NOTED FAILURE DURING PRODUCTION, IT IS BELIEVED THAT THE DEFECTIVE PRODUCT WAS NOT CAUGHT DURING THE REJECTION PROCESS. FINAL PRODUCTS ARE SAMPLED FROM THE MANUFACTURING LINE AND SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS TO PREVENT THE DISTRIBUTION OF DEFECTIVE PRODUCT. PROPER MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THIS INCIDENT. DIT HAS BEEN RECEIVED 1 PICTURE FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PICTURE RECEIVED IT CAN BE OBSERVED A 10ML LS SYRINGE WITH THE SCALE PARTIALLY MISSING. IT IS MARKED ONLY UP TO 8ML. DHR OF LOT 1802016 HAS BEEN REVIEWED FINDING AN ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING MANUFACTURING PROCESS OF THIS LOT A FAILURE WAS DETECTED IN MARKING MACHINE WHICH CAUSED MISSING SCALE AND BAD MARKING. ONCE DETECTED DEFECTIVE SAMPLES WERE REJECTED AND MECHANICAL TEAM REPAIRED THE FAILURE. SO THIS FAILURE IS THE CAUSE OF THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ LUER-SLIP SYRINGE THERE WAS AN ISSUE WITH SCALE MARKING ERROR. IT WAS STATED ¿THERE WERE 10 ML SYRINGES THAT ONLY GO UP TO 8 MLS". THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383652 BD PLASTIPAK¿ LUER-SLIP SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1802016

    Patients

    Seq Age Sex Outcome Treatment
    1 Other