BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 9355141 · Received November 21, 2019

    Report

    Report Number
    1213809-2019-01156
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 1, 2019
    Report Date
    January 20, 2020
    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

    ONE 1ML S/T SYRINGE WITH SAFETYGLIDE NEEDLE INSIDE AN OPENED BLISTER PACKAGE WAS RECEIVED. THE PACKAGE WAS CONFIRMED TO BE FROM BATCH #8355914 (P/N 305903). THE SAMPLE WAS VISUALLY EVALUATED. THE BARREL WAS OBSERVED TO HAVE MAJOR DAMAGE TO THE TIP AND BARREL ROOF AREA NEAR THE ZERO LINE ON ONE SIDE. THE DAMAGE APPEARED TO BE A DEEP SCRATCH MARK AND IS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8355914 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION 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 WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN SYRINGE.

    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 WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154477 BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 305903 8355914 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other