BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 8101850 · Received November 26, 2018

    Report

    Report Number
    1213809-2018-00844
    Event Type
    Malfunction
    Date Received
    November 26, 2018
    Date of Event
    November 8, 2018
    Report Date
    January 23, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    FMF
    UDI-DI
    30382903009122
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE 10ML SYRINGE IN AN OPENED PACKAGE FROM BATCH #8060881 (B)(4). WAS RECEIVED. IT WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE JAMMED STOPPER. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. CONTROLS ARE IN PLACE THAT INCLUDE HOURLY INSPECTIONS FOR ALL DEFECTS TO ENSURE CONTAINMENT OF DEFECT AND QUALITY OF THE FINAL PRODUCT. THE AQL FOR INCORRECT ASSEMBLY IS 0.65%. THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF 504,000, WHICH IS 0.0002%. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH DAMAGED PRODUCT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.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 WITH THE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH DAMAGED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940501 BD SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON, DICKINSON & CO. 8060881 30382903009122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other