BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 8506955 · Received April 11, 2019

    Report

    Report Number
    2243072-2019-00719
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 13, 2019
    Report Date
    April 18, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    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

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, AND NO ROOT CAUSE CAN BE DETERMINED, AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE TIP NEEDED TO BE TIGHTENED WITH AN UNSPECIFIED BD SYRINGE¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE REPLACEMENT CARTRIDGES SHE RECEIVED HAD THE SAME ISSUE AS HER PREVIOUS CARTRIDGES (COM-354536). CUSTOMER REPORTS THAT SHE IS ABLE TO CONTINUOUSLY REMOVE AIR FROM HER CARTRIDGE. CUSTOMER HAS TRIED 4 CARTRIDGES SO FAR TODAY FROM LOT M 220646 AND EXPERIENCED THE SAME EXACT ISSUE. WAS REQUESTED CUSTOMER CAPTURE A PHOTO OR VIDEO OF THE RELATIVE SIZE AND QUANTITIES OF AIR BUBBLES THAT SHE IS EXPERIENCING. CUSTOMER HAS NOT YET FILLED A CARTRIDGE SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    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. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE TIP NEEDED TO BE TIGHTENED WITH AN UNSPECIFIED BD SYRINGE¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE REPLACEMENT CARTRIDGES SHE RECEIVED HAD THE SAME ISSUE AS HER PREVIOUS CARTRIDGES ((B)(4)). CUSTOMER REPORTS THAT SHE IS ABLE TO CONTINUOUSLY REMOVE AIR FROM HER CARTRIDGE. CUSTOMER HAS TRIED 4 CARTRIDGES SO FAR TODAY FROM LOT M 220646 AND EXPERIENCED THE SAME EXACT ISSUE. WAS REQUESTED CUSTOMER CAPTURE A PHOTO OR VIDEO OF THE RELATIVE SIZE AND QUANTITIES OF AIR BUBBLES THAT SHE IS EXPERIENCING. CUSTOMER HAS NOT YET FILLED A CARTRIDGE SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300522 UNSPECIFIED BD SYRINGE SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other