BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE

    MDR report key: 12207230 · Received July 21, 2021

    Report

    Report Number
    1213809-2021-00506
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 23, 2021
    Report Date
    July 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095712
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO SHOWED A BOX LABEL FROM BATCH #1090648. ONE PHOTO SHOWED A CLOSE-UP OF A SYRINGE NEEDLE (P/N 309571), VISIBLE STRANDS OF FOREIGN MATTER COULD BE SEEN EXTENDING FROM THE CANNULA. THIS FOREIGN MATTER WHICH APPEARED TO BE METAL SHAVINGS AND WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE PHOTOS WILL BE FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. FURTHER INVESTIGATION WAS PERFORMED. TWO PHOTOS WERE PROVIDED. ONE PHOTO SHOWS A CASE LABEL. THE OTHER PHOTO SHOWS A NEEDLE ASSEMBLY WITH NO PLASTIC SHIELD. THE NEEDLE HAS A STRING OF FOREIGN MATERIAL TOWARDS THE NEEDLE TIP. FROM THE PHOTO THERE IS NO WAY TO CONFIRM THE FOREIGN MATTER MATERIAL. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I OPENED A NEW SYRINGE NEEDLE AND NOTICED A HAIR OR METAL SLIVER ON THE END OF THE NEEDLE (IT WAS HARD TO TELL) I PUT THE CAP ON, THEN REMOVED THE CAP, PULL THE PLUNGER BACK TO GET THE LIQUID OUT OF THE NEEDLE, PUT THE CAP BACK ON, REPLACED THE NEEDLE.

    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 BD 3ML SYRINGE LUER-LOK¿ TIP WITH BD PRECISIONGLIDE¿ NEEDLE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I OPENED A NEW SYRINGE NEEDLE AND NOTICED A HAIR OR METAL SLIVER ON THE END OF THE NEEDLE (IT WAS HARD TO TELL) I PUT THE CAP ON, THEN REMOVED THE CAP, PULL THE PLUNGER BACK TO GET THE LIQUID OUT OF THE NEEDLE, PUT THE CAP BACK ON, REPLACED THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1101023 BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309571 1090648 30382903095712

    Patients

    Seq Age Sex Outcome Treatment
    1