BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

    MDR report key: 7495849 · Received May 8, 2018

    Report

    Report Number
    3003152976-2018-00187
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 27, 2018
    Report Date
    May 16, 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
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    BD RECEIVED 1 UNUSED SAMPLE OF 10LL LOT 1802007. UPON VISUAL INSPECTION OF THE SAMPLE RECEIVED IT CAN BE OBSERVED THE SCALE IS 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 DEFECTIVE SAMPLES WERE REJECTED AND MECHANICAL TEAM REPAIRED THE FAILURES. THESE FAILURES WERE THE ROOT CAUSE OF THE DEFECT OF THE SYRINGE RECEIVED. 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. BASED ON SEVERITY AND OCCURRENCE NO FORMAL CAPA IS REQUIRED ACCORDING TO INTERNAL PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ THERE WAS AN ISSUE WITH A SCALE MARKING ERROR. IT WAS STATED ¿THE SCALE ON THE SYRINGE IS PRINTED INCORRECTLY AND OBLIQUE. THEREFORE THEY ARE NOT USABLE FOR CARRYING OUT PREPARATIONS.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336124 BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 1802007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other