BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB

    MDR report key: 8664442 · Received June 3, 2019

    Report

    Report Number
    8041187-2019-00421
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 11, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057895
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTO EVALUATION: 2 PHOTOS WERE RECEIVED FOR INVESTIGATION. UNABLE TO OBSERVE ANY DAMAGE/DISTORTED BARREL FROM THE PHOTO BUT OBSERVED INK SMEAR ON THE SYRINGE BARREL. SAMPLE EVALUATION: 1 UNUSED ACTUAL SAMPLE IN OPEN PACKAGED WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS NOT DECONTAMINATED. THE 1 ACTUAL SAMPLE WAS SUBJECTED TO VISUAL INSPECTION FOR DAMAGE SYRINGE. OBSERVED THE FOLLOWING FROM THE SAMPLE. MISSING SCALE MARKING AND INK SMEAR ON THE SYRINGE BARREL. DAMAGE ON SYRINGE BARREL AND SYRINGE TIP. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. CONCLUSION: MACHINE LOGS INDICATE ADJUSTMENTS WERE MADE TO THE MARKING ASSEMBLY DURING THE MANUFACTURE OF THIS BATCH. POTENTIAL ROOT CAUSE FOR THE DAMAGED FLANGE AND FOREIGN MATTER DEFECTS ARE ASSOCIATED WITH THE MARKING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB EXPERIENCED PRODUCT DAMAGE/DEFORMATION, AND SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED BARREL.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: FMI, FMF. (B)(4). 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 SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB EXPERIENCED PRODUCT DAMAGE/DEFORMATION, AND SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458538 SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE; PISTON SYRINGE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8052070 30382903057895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other