BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ 2-PIECE SYRINGE WITH BD MICROLANCE¿ NEEDLE

    MDR report key: 7137151 · Received December 21, 2017

    Report

    Report Number
    3002682307-2017-00151
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 1, 2017
    Report Date
    January 26, 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
    MU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE EVALUATION: WE HAVE BEEN PROVIDED WITH ONE REFERENCE SAMPLE. THE EVALUATION OF THE SAMPLE DID NOT REVEAL ANY FUNCTIONALITY ISSUE. WE HAVE PERFORMED THE SLIDING TEST FOR THE RETURNED SAMPLE AND ALL VALUES WERE FOUND WITHIN SPECIFICATIONS. BHR REVIEW: 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 Nº2020 (JULY 13 - 15TH, 2015). SYRINGES WERE ASSEMBLED IN IN LOT #5191392, #5174462. RESEARCH HAS FOUND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE. WE HAVE ALSO REVIEWED THE BARREL LOTS #5191308, #5183336, #5155464, #5174445, #5162256, AND #5155463 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PLUNGER LOTS #5174452, #5191312, #5183342, #5155568, AND #5162265 AND NO PROBLEMS, DEFECTS OR QN RELATED TO THE REPORTED ISSUE WERE FOUND. WE HAVE ALSO REVIEWED THE PERFORMED SLIDING TEST FOR THIS LOT (JULY 16TH, 2017), AND ALL VALUES WERE WITHIN SPECIFICATIONS. CONCLUSION: THE RETURNED SAMPLE DID NOT PRESENT THE REPORTED FUNCTIONALITY DEFECT. WE COULD NOT CONFIRM THE REPORTED ISSUE. ROOT CAUSE ANALYSIS: THE RETURNED SAMPLE DID NOT PRESENT ANY FUNCTIONALITY ISSUE. WE CAN STATE THAT THE SYRINGES REPORTED MEET THE PRODUCT SPECS AND RECOMMENDED VALUES IN THE PRODUCT STANDARDS. ON THE OTHER HAND, EITHER THE MEDICATION/DRUG USED BY THE CUSTOMER OR A SPECIAL METHOD OF USE (HIGH TEMPERATURES, PRESSURES, SEVERAL USES, ETC.) COULD AFFECT THE SLIDING PROPERTIES OF THE SYRINGES.

    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 THE PLUNGER ON A BD DISCARDIT¿ 2-PIECE SYRINGE WITH BD MICROLANCE¿ NEEDLE PACKED ASIDE WAS DIFFICULT TO MOVE, REQUIRING A LOT OF PRESSURE TO ADMINISTER THE MEDICATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917004 BD DISCARDIT¿ 2-PIECE SYRINGE WITH BD MICROLANCE¿ NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON, S.A. 1507163

    Patients

    Seq Age Sex Outcome Treatment
    1 Other