BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II SYRINGE

    MDR report key: 8591968 · Received May 8, 2019

    Report

    Report Number
    3002682307-2019-00289
    Event Type
    Malfunction
    Date Received
    May 8, 2019
    Date of Event
    April 22, 2019
    Report Date
    June 6, 2019
    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
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH A PHOTO FOR CATALOG 309110, LOT 1902113, TO INVESTIGATE FOR THIS RECORD. A LEAKAGE THROUGH THE PLUNGER OF THE SYRINGE WAS OBSERVED IN THIS PICTURE VERIFYING THE REPORTED ISSUE. BD CONCLUDES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED BECAUSE OF A DAMAGE IN THE PLUNGER LIP. THIS COULD BE PRODUCED DURING THE HANDLING OF THE PRODUCT THROUGH THE MANUFACTURING PROCESS OR IN THE PLUNGER ASSEMBLY MACHINE. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD DISCARDIT¿ II SYRINGES LEAKED BLOOD FROM THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "WHILE BLOOD COLLECTION THERE IS A BLOOD LEAKAGE TO THE PLUNGER, WHICH CAN GENERATE A SAMPLE CONTAMINATION AND A POTENTIALLY RISK OF BLOOD EXPOSURE TO HEALTH PROFESSIONALS."

    Additional Manufacturer Narrative · 1

    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 2 BD DISCARDIT¿ II SYRINGES LEAKED BLOOD FROM THE PLUNGER DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "WHILE BLOOD COLLECTION THERE IS A BLOOD LEAKAGE TO THE PLUNGER, WHICH CAN GENERATE A SAMPLE CONTAMINATION AND A POTENTIALLY RISK OF BLOOD EXPOSURE TO HEALTH PROFESSIONALS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386984 BD DISCARDIT II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1902113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other