BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD¿ BD LUER-LOC¿ TIP SYRINGE AND NEEDLE

    MDR report key: 8861391 · Received August 5, 2019

    Report

    Report Number
    3003916417-2019-00375
    Event Type
    Malfunction
    Date Received
    August 5, 2019
    Date of Event
    July 18, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE BATCH HISTORY ANALYSIS WAS PERFORMED, QUALITY NOTIFICATIONS AND MAINTENANCE RECORDS VERIFIED. NO RECORDS RELATED TO INCIDENT WERE OBSERVED. THE PHOTOS WERE ANALYZED AND IT WAS NOT POSSIBLE TO OBSERVE FM. AT MENTIONED REGION IT WAS POSSIBLE TO IDENTIFY SINK IN THE MOLDED COMPONENT, NOT IN CONTACT WITH FLUID PATH. THIS SINK IS A DEFORMATION FROM THE PLASTIC INJECTION PROCESS. IN THIS CASE, IT IS THE DIFFICULT TO PACK THE MATERIAL DURING THE MOLD FILLING PHASE IN THE INJECTION PROCESS. THE BARREL COMPONENT IS PRODUCED BY THE PLASTIC INJECTION PROCESS, WHERE HEATED PLASTIC MATERIAL IS INJECTED AGAINST A MOLD FOR FORMING THE PRODUCT. THIS SINK OCCURS AT EXTERNAL PORTION OF THE BARREL WALL, SO THERE IS NO RISK OF CONTACT WITH THE INNER WALL OF THE COMPONENT. THUS IT IS POSSIBLE CONCLUDE THIS IS AN ESTHETIC DEFECT, NOT RELATED WITH FOREIGN MATTER, AND THERE IS NO RISK TO THE PATIENT IN USE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD EMERALD¿ BD LUER-LOC¿ TIP SYRINGE AND NEEDLE HAS BEEN FOUND CONTAINING AIR BUBBLES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PRODUCT HAS BUBBLES IN THE TIP, WHICH MAY PRESENT A PROBLEM IN THE USER, THE REGULATIONS ARE NOT MET.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD EMERALD¿ BD LUER-LOC¿ TIP SYRINGE AND NEEDLE HAS BEEN FOUND CONTAINING AIR BUBBLES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PRODUCT HAS BUBBLES IN THE TIP, WHICH MAY PRESENT A PROBLEM IN THE USER, THE REGULATIONS ARE NOT MET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656755 BD EMERALD¿ BD LUER-LOC¿ TIP SYRINGE AND NEEDLE HYPODERMIC SYRINGE AND NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9044945

    Patients

    Seq Age Sex Outcome Treatment
    1 Other