BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 10 ML DISPOSABLE STERILE SYRINGE WITH NEEDLE

    MDR report key: 7137128 · Received December 21, 2017

    Report

    Report Number
    3002682307-2017-00129
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 21, 2017
    Report Date
    January 13, 2018
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE BEEN PROVIDED WITH A PICTURE AND THE AFFECTED SAMPLE. VISUAL INSPECTION OF THE SAMPLE REVEAL A BREAKAGE OF THE SYRINGE BARREL WALL NEAR THE TIP. THAT CONFIRMED THE REPORTED ISSUE. 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 Nº2028 (B)(6) - (B)(6) 2017). SYRINGES WERE ASSEMBLED IN MACHINE Nº4253, Nº4235, Nº4213, Nº4212 AND Nº4203, IN LOT #7100071 (B)(6) - (B)(6) 2017), LOT #7112279 (B)(6) - (B)(6) 2017) AND LOT #7118093 (B)(6) - (B)(6) 2017). RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #7118052, #7114311, #7100034, #7083118, AND #7089482 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #7118053, #7114315, #7100039, #7083122, AND #7089483 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. THE RETURNED PICTURE OF THE SAMPLE PRESENTED THE REPORTED ISSUE. WE COULD CONFIRM THE REPORTED ISSUE. ROOT CAUSE ANALYSIS THE MATERIAL USED TO MANUFACTURE DISCARDIT SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLING MACHINES HAVE AN ON-LINE DETECTION SYSTEM THAT INSPECTS 100 % THE SYRINGES, REJECTING AUTOMATICALLY THE SYRINGES WITH BROKEN PARTS LIKE THE TIP OF THE BARREL. BASED ON THIS FACT, WE THINK THAT THE SYRINGE TIP COULD BREAK AS A CONSEQUENCE OF ANY IMPERCEPTIBLE DAMAGE IN THE BARREL AT THE MOMENT OF THE USE OR SOME STRONG CONDITION DURING HANDLING OR USE OF THE PRODUCT.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE FOUND SOLUTION LEAKING WHEN USING A BD¿ 10 ML DISPOSABLE STERILE SYRINGE WITH NEEDLE. THE NURSE REPORTED THAT THE TIP AND SYRINGE CONNECTION WAS FOUND BROKEN. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920382 BD¿ 10 ML DISPOSABLE STERILE SYRINGE WITH NEEDLE HYPODERMIC SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1705120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other