BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 8341058 · Received February 14, 2019

    Report

    Report Number
    1213809-2019-00187
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 25, 2019
    Report Date
    April 22, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: FOUR PHOTOS AND ONE 10ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH #8183678 (P/N 300912) WAS RECEIVED AND VISUALLY EVALUATED. IT WAS OBSERVED THAT ONE OF THE FLANGES WAS ALMOST REMOVED FROM THE BARREL WITH SURFACE SCRATCHES EXTENDING FROM IT. THERE WERE ALSO DEEP SCRATCHES ON THE BARREL NEAR THE TOP, MIDDLE, AND THE TIP CAUSING DEFORMATIONS. FURTHERMORE, 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 POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP HAD "A STRANGE DEFORMATION OF THE PLUNGER".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 SYRINGE LUER-LOK¿ TIP HAD "A STRANGE DEFORMATION OF THE PLUNGER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134956 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8183678 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other