BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 60ML CATHETER TIP

    MDR report key: 12756128 · Received November 7, 2021

    Report

    Report Number
    1911916-2021-01145
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 8, 2021
    Report Date
    October 18, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED THE CUSTOMER IDENTIFIED BREAK IN THE PLUNGER OF THE 60ML SYRINGE. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS THE TOP OF THE SYRINGE, WHICH IS DAMAGED. FOR THE DAMAGED PART DEFECT, IT IS LIKELY THAT A JAM OCCURRED DURING THE ASSEMBLY PROCESS RESULTING IN THE DAMAGE TO THE SYRINGE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302828, LOT NUMBER 9182636. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. ALIGNMENT OF THE RAILS AND CONVEYORS WAS GOOD. NO PINCH POINTS WERE DETECTED AND THE FLOW OF PRODUCTS WAS ACCEPTABLE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD SYRINGE 60ML CATHETER TIP, THE DEVICE EXPERIENCED A BROKEN PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IDENTIFIED BREAK IN THE PLUNGER OF THE 60ML SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1661963 BD SYRINGE 60ML CATHETER TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 9182636

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown