BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGES LS W/RED PLUNGER

    MDR report key: 8157557 · Received December 12, 2018

    Report

    Report Number
    8041187-2018-00474
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    November 20, 2018
    Report Date
    January 25, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: IN SECTION H.10 OF THE PREVIOUSLY SUBMITTED MDR, SECTIONS D.1 AND H.1 WERE INCORRECTLY REFERENCED AS THE MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FIVE PHOTOS WERE RETURNED FOR INVESTIGATION. RETURNED PHOTOS ON PLASTIPAK PRODUCT ARE NOT PRODUCED BY TUAS PLANT. RETURNED PHOTOS ON 5ML SYRINGE IS PRODUCED BY TUAS PLANT. NO ABNORMALITY FOUND ON SYRINGE TOP WEB PRINTING AND NO OBSERVATION THAT PACKAGING HAD BEEN CUT OFF. THE INVESTIGATION WAS NOT ABLE TO CONFIRM THE CUSTOMER EXPERIENCE. REQUIRE SAMPLE TO BE RETURNED FOR FURTHER INVESTIGATION. NO DHR COULD BE CARRIED OUT BECAUSE NO BATCH NUMBER WAS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGES LS W/RED PLUNGER HAD STERILITY BREACH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ SYRINGES LS W/RED PLUNGER HAD STERILITY BREACH.

    Additional Manufacturer Narrative · 1

    (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 BD¿ SYRINGES LS W/RED PLUNGER HAD STERILITY BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997730 BD¿ SYRINGES LS W/RED PLUNGER SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other