BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 7389147 · Received April 2, 2018

    Report

    Report Number
    1213809-2018-00210
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    March 26, 2018
    Report Date
    April 20, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096443
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A SINGLE BLACK AND WHITE PHOTO WAS RECEIVED DEPICTING TWO HEPARIN MEDICINE VIALS WITH NEEDLE CANNULAS STICKING OUT OF THE VIALS¿ STOPPERS. THE PRODUCT WAS REPORTED TO BE FROM BATCH #7210935 (P/N 309644). ONE VIAL WAS ALMOST EMPTY OF LIQUID AND ONE VIAL WAS MORE THAN HALF FULL OF LIQUID. THE CANNULAS IN THE PHOTO ARE BY THEMSELVES WITHOUT THE NEEDLE HUBS AND SYRINGES. THE CANNULAS ARE VISIBLY INSERTED AT AN ANGLE INTO THE STOPPERS AT APPROXIMATELY 30-45 DEGREES. A NEEDLE WHICH SEPARATES FROM THE NEEDLE HUB IS A REJECTABLE CONDITION. HOWEVER, IT APPEARS THAT THE NEEDLES WERE INSERTED INTO THE VIALS AT A LARGE ANGLE, INSTEAD OF PERPENDICULAR TO THE STOPPER, WHICH POTENTIALLY CONTRIBUTED TO THE FAILURE. SINCE NO SAMPLES WERE RETURNED AND THE PHOTO IS OF POOR QUALITY, FURTHER INVESTIGATION IS NOT POSSIBLE. BASED ON THE AVAILABLE INFORMATION, THE FAILURE CANNOT BE ATTRIBUTED TO THE MANUFACTURING PROCESS. DHR REVIEW FOR BATCH 7210935 (P/N 309644): MANUFACTURING DATES: 08/04/2017 TO 08/05/2017. BATCH QUANTITY WAS 360,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7210935 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE AND CAPA NOT REQUIRED BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 DURING USE OF THE BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE ¿THE CLINICAL MANAGER REPORTED THAT WHEN THE BD SYRINGE NEEDLE WAS INSERTED INTO VIAL TO DRAW UP MEDICATION, THE NEEDLE SEPARATED FROM THE HUB AND STUCK IN THE RUBBER STOPPER OF THE MEDICATION VIAL.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233945 BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 7210935 30382903096443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other