BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LS 22X1-1/4 DN EMERALD

    MDR report key: 9589878 · Received January 15, 2020

    Report

    Report Number
    3002682307-2020-00007
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    October 22, 2019
    Report Date
    February 6, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 30774319 LOT 1811360 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE. BD INVESTIGATED THIS TYPE OF CLOG ISSUE IN DETAIL IN THE PAST, PERFORMING DIFFERENT ANALYSIS OF MATERIAL CHARACTERIZATION LIKE FTIR AND CONDUCTING SIMULATED STUDIES OF THE EVENT THROUGH MULTIPLE TYPES OF CONTAINER AND NEEDLES. THE ANALYSIS OF RETURNED CLOGGED CANNULAS OF OTHER CUSTOMERS REVEALED A CONICAL IN SHAPE, SOFT TRANSPARENT MATERIAL WITH A FLAT SURFACE. FTIR SPECTRAL ANALYSIS IDENTIFIES THE MATERIAL CLOGGING THE NEEDLE AS POLYETHYLENE. IT WAS OBSERVED THAT THESE TYPES OF PARTICLE ARE COMMONLY GENERATED WHEN NEEDLES ARE USED TO ACCESS THE SEPTUM OF RIGID PLASTIC CONTAINERS OF SALINE OR OTHER MEDICATION SOLUTIONS. FURTHER INVESTIGATION SUGGESTED THAT THE BD MICROLANCE¿ NEEDLE HAD BEEN USED TO ACCESS RIGID PLASTIC CONTAINERS OF SALINE OR OTHER MEDICATION SOLUTIONS DESIGNED TO HAVE A DOUBLE SEPTUM, THE FIRST IS A NORMAL RUBBER CLOSURE, THE SECOND IS A THICK POLYETHYLENE SEPTUM. BD HAS TO CONSIDER THAT BD MICROLANCE NEEDLES ARE DESIGNED MANUFACTURED WHOSE PRIMARY USE IS INTENDED TO PENETRATE THE SKIN AND RUBBER CLOSURES OF VIALS. THE ARE NOT DESIGNED TO PENETRATE THICK POLYETHYLENE MEMBRANES. THE DEVICE HISTORY REVIEW SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 5ML LS 22X1-1/4 DN EMERALD EXPERIENCED PRODUCT DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID COULDN'T BE ABSORBED BY SYRINGE DURING USE.

    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 SYRINGE 5ML LS 22X1-1/4 DN EMERALD EXPERIENCED PRODUCT DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LIQUID COULDN'T BE ABSORBED BY SYRINGE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57334 SYRINGE 5ML LS 22X1-1/4 DN EMERALD SYRINGE FMF BECTON DICKINSON, S.A. 1811360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other