BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD UNDISCLOSED PREFILLED SYRINGE

    MDR report key: 18184201 · Received November 21, 2023

    Report

    Report Number
    1423507-2023-00107
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    July 13, 2023
    Report Date
    November 3, 2023
    Manufacturer
    BD MEDICAL, MEDICATION DELIVERY SOLUTIONS
    Product Code
    NGT
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED. D. D. THE MATERIAL AND/OR LOT NUMBER PROVIDED HAVE NOT BEEN FOUND AND CANNOT BE VERIFIED. IN THIS MDR, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1 AS THE MANUFACTURING SITE CANNOT BE VERIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD UNDISCLOSED PREFILLED SYRINGE LEAKS DURING FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: INTERNAL MEDICINE REACTION: BIDI MEDICAL DEVICES (SHANGHAI) CO., LTD., THE PREFILLED CATHETER IRRIGATOR WILL LEAK OUT THE MEDICINAL LIQUID AT THE CONNECTION DURING FLUSHING, AFFECTING THE THERAPEUTIC EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000955 BD UNDISCLOSED PREFILLED SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL, MEDICATION DELIVERY SOLUTIONS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown