BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD BLOOD TRANSFUSION SETS (WITHOUT STOPCOCKS AND/OR Y-SITE)

    MDR report key: 15499921 · Received September 28, 2022

    Report

    Report Number
    2243072-2022-01680
    Event Type
    Malfunction
    Date Received
    September 28, 2022
    Date of Event
    September 13, 2022
    Report Date
    September 13, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 (B)(4) NJ HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. NO SAMPLES WERE RECEIVED FOR INVESTIGATION OF COMPLAINT REFERENCE (B)(4) REPORTED VIA POST MARKET SURVEY; HOWEVER THE CUSTOMER HAS INDICATED THAT A LEAKAGE WAS IDENTIFIED DURING USE OF A BD TRANSFUSION SET. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. IN THIS INSTANCE A LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. IN THIS INSTANCE, WITHOUT THE COMPLAINT SAMPLE OR ADDITIONAL INFORMATION ABOUT THE EXACT NATURE OF THE DEFECT IT IS NOT POSSIBLE TO CONCLUSIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE UNSPECIFIED BD BLOOD TRANSFUSION SETS (WITH STOPCOCKS AND/OR Y-SITE)THE CLINICIAN AND/OR PATIENT EXPERIENCED A LEAKAGE OF BLOOD/BLOOD PRODUCTS. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIAN EXPERIENCED: LEAKAGE - 1 - NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1934787 UNSPECIFIED BD BLOOD TRANSFUSION SETS (WITHOUT STOPCOCKS AND/OR Y-SITE) INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown