BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20 ML SYRINGE WITH NEEDLE

    MDR report key: 7570685 · Received June 5, 2018

    Report

    Report Number
    3002682307-2018-00135
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    May 17, 2018
    Report Date
    June 12, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    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 · 0

    INVESTIGATION SUMMARY: BD HAS BEEN PROVIDED WITH A PICTURE AND A REFERENCE SAMPLE TO INVESTIGATE FOR THIS RECORD. A LEAKAGE THROUGH THE PLUNGER ROD WAS OBSERVED IN PICTURES PROVIDED. UNFORTUNATELY, THE SAMPLE RETURNED WAS A REFERENCE SAMPLE THAT DID NOT PRESENT ANY DEFECTS. FOR THIS REASON, BD WAS ABLE VERIFY THE REPORTED ISSUE USING THE PHOTOS PROVIDED. BHR REVIEW: WE HAVE REVIEWED OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NEITHER QN NOR NCMR'S. SYRINGES WERE PACKED IN MACHINE Nº2011 (OCTOBER 3 - 5TH, 2017). SYRINGES WERE ASSEMBLED IN MACHINE, Nº4252, AND Nº4251, IN LOT #7269127 (OCTOBER 2 - 24TH, 2017) AND LOT #7244146 (SEPTEMBER 4 - 17TH, 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE BARREL LOTS #7244052, #7269061, AND #7271031, AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7251469, #7244053, #7237230, #7211171, #7234129, #7282420, #7269060, AND #7258045 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. BD BELIEVES THAT THE CAUSE OF THE PROBLEM COULD BE PRODUCED BECAUSE 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 RECOMMENDS THE USE OF 3 PCS BD SYRINGES WITH LUER LOCK TIP TO ADMINISTER MEDICATION VIA A SYRINGE PUMP. THE BD 3 PCS 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 HORIZONTALLY. THIS IS TO AVOID THAT THE DIFFERENCE IN PRESSURE BETWEEN ATMOSPHERE AND VEIN COULD LEAD THE SYRINGE TO EMPTY BY ITS OWN. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD LEAKED FROM THE TOP OF THE PLUNGER ROD OF A BD¿ 20 ML SYRINGE WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410378 BD¿ 20 ML SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMI BECTON DICKINSON, S.A. 1710207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other