BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7965440 · Received October 15, 2018

    Report

    Report Number
    1213809-2018-00667
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 25, 2018
    Report Date
    November 26, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: 8150891. MEDICAL DEVICE EXPIRATION DATE: 5/31/2023. DEVICE MANUFACTURE DATE: 5/30/2018. INVESTIGATION SUMMARY: EIGHT 10ML SYRINGES WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. BATCH 8150891 (P/N 302995): ONE SAMPLE BAG CONTAINING THREE OPEN SYRINGES. NO FOREIGN MATTER WAS OBSERVED ON THE BARREL EXTERIOR AND NO DEFECTS OBSERVED. BATCH 8150911 (P/N 302995): ONE BAG CONTAINING ONE OPEN SYRINGE. BLACK FIBROUS IN APPEARANCE FOREIGN MATTER LARGER THAN LEVEL 3 IN SIZE WAS OBSERVED ON THE INSIDE OF THE BAG, ON THE BARREL SURFACE AS WELL AS ON THE OPENED PACKAGE¿S TOP WEB NEAR WHERE IT WAS RIPPED OPEN. THE FOREIGN MATTER ON THE PACKAGE HAD AN OILY STAIN AROUND IT, IT WAS OUTSIDE THE FLUID PATH. ONE BAG CONTAINING ONE OPEN SYRINGE WITH NEEDLE. THE BARREL EXTERIOR HAD BLACK FIBROUS-LOOKING FOREIGN MATTER ATTACHED LARGER THAN LEVEL 3 IN SIZE. THE FOREIGN MATTER WAS NEAR THE BOTTOM OF THE BARREL BETWEEN ZERO LINE AND 1ML. ONE BAG CONTAINING ONE OPEN AND TWO LOOSE SYRINGE, NO FOREIGN MATTER WAS OBSERVED. A SAMPLE WAS SUBMITTED FOR FOURIER TRANSFORM INFRARED ANALYSIS TO BETTER IDENTIFY THE FOREIGN MATTER FOUND. ANALYSIS WAS PERFORMED ON THE DARK MATERIAL OBSERVED ON THE BLISTER PACK OF A 10ML SYRINGE. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY POLYPROPYLENE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #S. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD SYRINGE LUER-LOK¿ TIP HAD MOLD AND OIL ON THEM. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    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 BD SYRINGE LUER-LOK¿ TIP HAD MOLD AND OIL ON THEM. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804778 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8150891 00382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other