BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 8890834 · Received August 13, 2019

    Report

    Report Number
    1213809-2019-00820
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903029953
    PMA / PMN Number
    K943141
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO LOOSE 10ML SYRINGES WITH MEDICATION LABELS AND ONE TOP WEB LABEL FROM BATCH 9101674 (P/N 302995) INSIDE A BIOHAZARD BAG WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THROUGH THE BAG, BOTH OF THE SYRINGES EACH HAD A LENGTHWISE CRACK WITH A PUNCTURE MARK IN THE MIDDLE, OUTSIDE THE GRAD LINES. ONE CRACK EXTENDED FROM THE 4ML LINE TO ABOVE THE BD LOGO. ONE CRACK EXTENDED FROM THE 1ML LINE TO THE 10ML LINE. BOTH SYRINGES ARE 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 9101674 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.

    Description of Event or Problem · 0

    MATERIAL NO: 302995, BATCH NO: 9101674. IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WERE CRACKS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN STERILE SYRINGES ARE OPENED, FACILITY NOTICES CRACKS ON THE BARREL.

    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 AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 302995, BATCH NO: 9101674. IT WAS REPORTED THAT BEFORE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WERE CRACKS ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN STERILE SYRINGES ARE OPENED, FACILITY NOTICES CRACKS ON THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683820 BD SYRINGE LUER-LOK¿ TIP HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 9101674 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other