BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ SYRINGE 10ML

    MDR report key: 17795646 · Received September 21, 2023

    Report

    Report Number
    2243072-2023-01701
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    September 7, 2023
    Report Date
    January 8, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    07891463003782
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, DAMAGED BARREL IS OBSERVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED MAINTENANCE RECORDS RELATED TO THE INCIDENT. AN ADJUSTMENT WAS MADE AND REPAIR WAS CARRIED OUT ON THE TRANSFER GUIDE, MONITORING AND RELEASE OF THE EQUIPMENT. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER.

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFO RECEIVED. ¿ WHAT IS THE BATCH OF THE PRODUCT? 3012284. ¿ HOW MANY UNITS WERE IDENTIFIED WITH THE REPORTED CONDITION? 1 BOX WITH 250 UNITS. ¿ HAS THERE BEEN ANY IMPACT TO THE PATIENT? (DETAIL). INCREASES INFILTRATION TO THE CATHETER WHEN CHANNELING. ¿ HAS THERE BEEN EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE MUCOUS MEMBRANES OR SKIN? (DETAIL) THERE WAS NO EXPOSURE OF BLOOD OR CHEMOTHERAPY TO THE MUCOSA. ¿ WAS THERE A NEED FOR MEDICAL INTERVENTION DUE TO WHAT HAPPENED (MEDICATION ADMINISTRATION, ETC.)? (DETAIL). THERE WAS NO MEDICAL INTERVENTION. ¿ IS THE SAMPLE RELATED TO THE INCIDENT AVAILABLE FOR ANALYSIS? THERE ARE NO SAMPLES AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL TIP OF THE UNSPECIFIED BD¿ SYRINGE 10ML CAME OFF DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH: "THE BARREL TIP OF THE SYRINGE COMES OFF WHEN USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614331 UNSPECIFIED BD¿ SYRINGE 10ML PISTON SYRINGE FMF BECTON DICKINSON 3012284 07891463003782

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown