BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 8982514 · Received September 10, 2019

    Report

    Report Number
    1213809-2019-00916
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 16, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903059035
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND ONE LOOSE 1ML S/T SYRINGE WITH NEEDLE FROM SAFETYGLIDE COMBO PACKAGE WERE RECEIVED, ALONG WITH PACKAGE FROM BATCH#: 8355914 (P/N: 305903). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS OBSERVED TO HAVE SEVERE DAMAGE DENTING THE BARREL WALL AT AN ANGLE BETWEEN APPROXIMATELY 0.3ML AND THE ZERO LINE MARKINGS. THE DAMAGE RESULTED IN REMOVING SOME OF THE SCALE MARKINGS AS WELL. THE DAMAGE OBSERVED IS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THE SYRINGE SHAPE IS DISTORTED AND TWISTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE SHAPE DISTORTION AND TWISTED.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: K980580 (SYRINGE) K951254 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE THE SYRINGE SHAPE IS DISTORTED AND TWISTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE SHAPE DISTORTION AND TWISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780589 BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8355914 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other