BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE

    MDR report key: 12543541 · Received September 28, 2021

    Report

    Report Number
    1213809-2021-00674
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 20, 2021
    Report Date
    November 19, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: FOUR PHOTOS, A STRIP OF TOP WEB FROM BATCH 1133615 AND A LOOSE 5ML SYRINGE (P/N 309646) WITH CUSTOMER ATTACHED NEEDLE WERE RECEIVED. THE PHOTOS SHOWED A BLACK SPECK OF FOREIGN MATTER ON THE SYRINGE NEAR THE "2" NUMERAL. THE SAMPLE WAS VISUALLY EVALUATED POST DECONTAMINATION. THE BLACK SPECK WAS NOT PRESENT IN THE SAME LOCATION AS THE PHOTO; HOWEVER, A BLACK SPECK OF FOREIGN MATTER WAS PRESENT ON THE STOPPER INSIDE THE FLUID PATH OF THE SYRINGE. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS SHOWED THE PARTICLE TO MOST LIKELY BE POLY(ISOBUTENE) WITH SPECTRA ANALYSIS BEING LIKE THAT OF THE STOPPER MATERIAL. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND FLOATING IN THE BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE ONCE DRAWING UP FLUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A REPORT OF A 5ML SYRINGE WITH BLACK PARTICULATE FLOATING ONCE A FLUID WAS PULLED IN." "TECH WAS PULLING UP CONTRAST INTO A BD 5ML SYRINGE, GAD FROM A 2ML VILE, AND NOTICED A COUPLE PIECES OF BLACK FLOATING IN THE SYRINGE. SHE BROUGHT IT TO THE ATTENTION OF THE LEAD, WHO INSTRUCTED HER TO USE A DIFFERENT SIZE VILE AND LOT FOR THE CONTRAST. NO ISSUES WITH SECOND SYRINGE."

    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 BLACK FOREIGN MATTER WAS FOUND FLOATING IN THE BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE ONCE DRAWING UP FLUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A REPORT OF A 5ML SYRINGE WITH BLACK PARTICULATE FLOATING ONCE A FLUID WAS PULLED IN." "TECH WAS PULLING UP CONTRAST INTO A BD 5ML SYRINGE, GAD FROM A 2ML VILE, AND NOTICED A COUPLE PIECES OF BLACK FLOATING IN THE SYRINGE. SHE BROUGHT IT TO THE ATTENTION OF THE LEAD, WHO INSTRUCTED HER TO USE A DIFFERENT SIZE VILE AND LOT FOR THE CONTRAST. NO ISSUES WITH SECOND SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439554 BD LUER-LOK¿ STERILE, SINGLE USE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309646 1133615 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown