BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8956134 · Received September 3, 2019

    Report

    Report Number
    3003152976-2019-00597
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 13, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THREE PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PHOTOS IT WAS OBSERVED THAT THE SCALE OF ONE OF THE SYRINGES IS NOT PROPERLY PLACED. A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY DOCUMENTED QUALITY ISSUES DURING THE PRODUCTION OF SUSPECTED LOT 903208, 1903214, 902217, 1903216,1903211, AND1807237 THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. PRODUCT UNDERGOES VISUAL INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY OF THE DEVICE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT LIKELY OCCURRED DUE A DEFECT WITH THE PAD THAT TRANSFERS THE SCALE TO THE BARREL. AS A RESULT, THE PAD WAS PLACED INCORRECTLY DURING THE MARKING PROCESS WHICH LEAD TO THE DEFECT IDENTIFIED IN THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE IS AN ISSUE WITH SCALE MARKINGS ON THE SYRINGE. THE LEFT SIDE STARTS AND A DIFFERENT AREA THAN THE RIGHTS SIDE. THIS HAS LED TO A DISCREPANCY IN VOLUMES, WITH A 5 ML VOLUME DIFFERENCE OVER 16 SYRINGES WHICH LED TO A BATCH FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE WITH THE SYRINGES IS THAT THE GRADUATIONS START AT DIFFERENT POINTS ON THE SYRINGE. THE ONE ON THE LEFT STARTS RIGHT AT THE TOP AND THE ONE ON THE RIGHT IS VISIBLY LOWER. THIS HAS LED TO A DISCREPANCY IN VOLUMES, WITH A 5 ML VOLUME DIFFERENCE OVER 16 SYRINGES WHICH LED TO A BATCH 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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THERE IS AN ISSUE WITH SCALE MARKINGS ON THE SYRINGE. THE LEFT SIDE STARTS AND A DIFFERENT AREA THAN THE RIGHTS SIDE. THIS HAS LED TO A DISCREPANCY IN VOLUMES, WITH A 5 ML VOLUME DIFFERENCE OVER 16 SYRINGES WHICH LED TO A BATCH FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE WITH THE SYRINGES IS THAT THE GRADUATIONS START AT DIFFERENT POINTS ON THE SYRINGE. THE ONE ON THE LEFT STARTS RIGHT AT THE TOP AND THE ONE ON THE RIGHT IS VISIBLY LOWER. THIS HAS LED TO A DISCREPANCY IN VOLUMES, WITH A 5 ML VOLUME DIFFERENCE OVER 16 SYRINGES WHICH LED TO A BATCH FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750048 BD PLASTIPAK CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other