BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8460889 · Received March 28, 2019

    Report

    Report Number
    1213809-2019-00385
    Event Type
    Malfunction
    Date Received
    March 28, 2019
    Date of Event
    March 8, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE PHOTO AND ONE LOOSE INTEGRA SYRINGE WITH TWO MEDICATION VIALS WERE RECEIVED AND VISUALLY EVALUATED. THE STOPPER OF THE SYRINGE WAS FOUND TO HAVE A HOLE IN IT. FURTHERMORE, 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. CAPA#183493 WAS COMPLETED TO ADDRESS HOLE IN THE STOPPER MOLDING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN DRAWING UP VACCINE WITH BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE, THE VACCINE LEAKED OUT THE BOTTOM OF THE SYRINGE. PER CUSTOMER EMAIL: I SPOKE WITH YOU EARLIER ABOUT HAVING A FAULTY BD INTEGRA SYRINGE. THE PROBLEM THAT WE HAD WITH THIS SYRINGE IS THAT WHEN I WAS DRAWING UP A SHINGRIX VACCINATION FOR A PATIENT, THE VACCINE STARTED TO LEAK OUT OF THE BOTTOM OF THE SYRINGE. I WAS UNABLE TO ADMINISTER THE DOSE TO THE PATIENT BECAUSE OF THIS. SHINGRIX IS CURRENTLY ON A NATIONWIDE BACKORDER, AND IT IS IN VERY HIGH DEMAND. IT IS ALSO ABOUT $150.00 PER DOSE THAT WAS LOST AS WELL. PLEASE LET ME KNOW IF YOU HAVE ANY OTHER QUESTIONS OR NEED MORE INFORMATION ON THE INCIDENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. 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 WHEN DRAWING UP VACCINE WITH BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE, THE VACCINE LEAKED OUT THE BOTTOM OF THE SYRINGE. PER CUSTOMER EMAIL: I SPOKE WITH YOU EARLIER ABOUT HAVING A FAULTY BD INTEGRA SYRINGE. THE PROBLEM THAT WE HAD WITH THIS SYRINGE IS THAT WHEN I WAS DRAWING UP A SHINGRIX VACCINATION FOR A PATIENT, THE VACCINE STARTED TO LEAK OUT OF THE BOTTOM OF THE SYRINGE. I WAS UNABLE TO ADMINISTER THE DOSE TO THE PATIENT BECAUSE OF THIS. SHINGRIX IS CURRENTLY ON A NATIONWIDE BACKORDER, AND IT IS IN VERY HIGH DEMAND. IT IS ALSO ABOUT (B)(6) PER DOSE THAT WAS LOST AS WELL. PLEASE LET ME KNOW IF YOU HAVE ANY OTHER QUESTIONS OR NEED MORE INFORMATION ON THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255570 BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 7030994 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other