BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 8351603 · Received February 19, 2019

    Report

    Report Number
    1911916-2019-00194
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    October 1, 2018
    Report Date
    April 25, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903051565
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS ARE AS FOLLOWS: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT A 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE IS NOT INJECTING FULL DOSE, AND LEAVES 0.5ML OF PRODUCT IN THE SYRINGE. THE PLUNGER STOPPER IN THE SYRINGE BARREL IS NOT FLUSH WITH THE BOTTOM. MEDICAL DEVICE BRAND NAME: 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE. MEDICAL DEVICE TYPE: FMF. COMMON DEVICE NAME: PISTON SYRINGE. MEDICAL DEVICE MANUFACTURER: MFG US CANAAN. MEDICAL DEVICE CATALOG #: 309597. MEDICAL DEVICE LOT #: 8059526. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. UNIQUE IDENTIFIER (UDI) #: 30382903095972. MANUFACTURING LOCATION: MFG US CANAAN. PMA / 510(K)#: K980987. DEVICE MANUFACTURE DATE: 2018-02-28.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE IS NOT INJECTING FULL DOSE, AND LEAVES 0.5ML OF PRODUCT IN THE SYRINGE. THE PLUNGER STOPPER IN THE SYRINGE BARREL IS NOT FLUSH WITH THE BOTTOM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE IS NOT INJECTING FULL DOSE, AND LEAVES 0.5ML OF PRODUCT IN THE SYRINGE. THE PLUNGER STOPPER IN THE SYRINGE BARREL IS NOT FLUSH WITH THE BOTTOM.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR? 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 A NEEDLE 22X1-1/2 RB I IS NOT INJECTING FULL DOSE, AND LEAVES 0.5ML OF PRODUCT IN THE SYRINGE. THE PLUNGER STOPPER IN THE SYRINGE BARREL IS NOT FLUSH WITH THE BOTTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143128 1 ML BD SLIP TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8059526 30382903051565

    Patients

    Seq Age Sex Outcome Treatment
    1 Other