BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 7158412 · Received January 2, 2018

    Report

    Report Number
    3002682307-2017-00141
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 11, 2017
    Report Date
    January 29, 2018
    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
    CH
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    WE HAVE BEEN PROVIDED WITH A PICTURE OF THE AFFECTED SAMPLE. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN THIS PROVIDED SAMPLE. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QA NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2011 (B)(6) - (B)(6) 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #7009441 (B)(6) - (B)(6) 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARRELS LOTS #7009458, AND #6328024 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7024025, #7016119, AND #7009457 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE DETERMINE THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED AS A CONSEQUENCE 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. BD HAS IDENTIFIED A COMBINATION OF FACTORS IN THE USAGE OF THE PRODUCT THAT WOULD GIVE A SAFER RESULT TO THE CUSTOMER. BD RECOMMENDS THE USE OF 3 PIECE BD SYRINGES WITH LUER LOCK TIP TO ADMINISTER MEDICATION VIA A SYRINGE PUMP. THE BD 3 PIECE SYRINGE HAS A NATURAL RUBBER STOPPER WHICH PROVIDES A SMOOTHER PERFORMANCE IN TERMS OF PLUNGER ADVANCEMENT AT LOW SPEED. IN ADDITION, A LUER LOCK FITTING ENSURE A SAFER CONNECTION WITH THE INFUSION LINE COMPARED TO A LUER SLIP TIP, THUS REDUCING THE RISK OF DISCONNECTION OF THE INFUSION LINE. IN ADDITION, IT IS PREFERABLE THAT THE SYRINGE PUMP IS PLACED AT THE SAME HEIGHT OF THE PATIENT, AND PLACED HORIZONTALLY. THIS IS TO AVOID THAT THE DIFFERENCE IN PRESSURE BETWEEN ATMOSPHERE AND VEIN COULD LEAD THE SYRINGE TO EMPTY ON ITS OWN. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF THE BD SYRINGE WITH NEEDLE THE NURSE FOUND THAT BLOOD LEAKED FROM THE PLUNGER ROD WHEN USED ON HEMODIALYSIS MACHINE. NO BLOOD EXPOSURE TO MUCOUS MEMBRANES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2604 BD¿ SYRINGE WITH NEEDLE HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON, S.A. 1701151

    Patients

    Seq Age Sex Outcome Treatment
    1 Other