BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿

    MDR report key: 16415194 · Received February 21, 2023

    Report

    Report Number
    1213809-2023-00105
    Event Type
    Malfunction
    Date Received
    February 21, 2023
    Date of Event
    January 17, 2023
    Report Date
    March 14, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096351
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 10-MAR-2023. H6: INVESTIGATION SUMMARY: TWO THOUSAND TWO HUNDRED NINETY-FIVE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED ON TWO HUNDRED SIXTY-TWO SAMPLES. ONE THOUSAND NINE HUNDRED NINETY-SIX SAMPLES WERE OBSERVED TO HAVE SMALL INK DOT ON THE BARREL ON THE OPPOSITE SIDE OF THE SCALE MARKING AREA. THE CONDITIONS OBSERVED ARE ACCEPTABLE PER PRODUCT SPECIFICATION. THIRTY-TWO SAMPLES HAD SIX OR MORE INK DOTS AND FIVE SAMPLES HAD ONE INK DOT IN THE NON-SCALE MARKING AREA. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE INK DOTS DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THIS DEFECT IS OCCURRING BELOW AN EXPECTED RATE SO NO CORRECTIVE ACTIONS WILL BE MADE AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2102324. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2295 OF THE BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿ EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 2,295 UNITS HAVE BLACK DOTS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2295 OF THE BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿ EXPERIENCED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(4) UNITS HAVE BLACK DOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227963 BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿ PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309635 2102324 30382903096351

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown