BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

    MDR report key: 7530265 · Received May 21, 2018

    Report

    Report Number
    3003152976-2018-00194
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 30, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PICTURE HAS BEEN RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PICTURE RECEIVED IT CAN BE OBSERVED 2 SYRINGES WITH THE SCALE ROTATED AND BLURRED. DHR OF LOT 1802007 HAS BEEN REVIEWED FINDING AN ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING MARKING PROCESS FAILURES WERE OBSERVED IN MARKING MACHINE THAT CAUSED DAMAGE AND ROTATED SCALE ON BARREL. ONCE DETECTED, THE DEFECTIVE SAMPLES WERE REJECTED AND THE MECHANICAL TEAM REPAIRED THE FAILURES. THESE FAILURES WERE THE ROOT CAUSE OF THE DEFECT OF THE SYRINGE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. VISUAL INSPECTION -MOLDING: 2 INJECTIONS PER SHIFT. -PRINTING: 24 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. -ASSEMBLY: 24 SAMPLES PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT AND ONCE AT THE BEGINNING OF THE SHIFT. -PRIMARY PACKAGING: 1 ADVANCE-STEP (WITH PRODUCT) PER TWO HOURS, AFTER ANY INTERVENTION IN THE EQUIPMENT, AND ONCE AT THE BEGINNING OF THE SHIFT. -SECONDARY PACKAGING: 1 SHELF-PACKAGE PER PALLET. FUNCTIONAL INSPECTION PRINTING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. ASSEMBLY: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. PRIMARY PACKAGING: ONCE IN THE FIRST PALLET AND ONCE IN LAST PALLET OF THE LOT. INVESTIGATION CONCLUSION: DHR OF LOT 1802007 HAS BEEN REVIEWED FINDING AN ANNOTATION RELATED TO THE ALLEGED DEFECT. DURING MARKING PROCESS FAILURES WERE OBSERVED IN MARKING MACHINE THAT CAUSED DAMAGE AND ROTATED SCALE ON BARREL. ONCE DETECTED, THE DEFECTIVE SAMPLES WERE REJECTED AND THE MECHANICAL TEAM REPAIRED THE FAILURES. THESE FAILURES WERE THE ROOT CAUSE OF THE DEFECT OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 WITH USE A BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ WAS FOUND WITH VOLUMETRIC INACCURACY AS " THE PRINTING ON 2 SYRINGES IS MISPLACED." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372803 BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ SYRINGE FMI BECTON DICKINSON, S.A. 1802007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other