BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD IVSS BLUE IV ACC WO TEGADERM MED GLVS

    MDR report key: 20276042 · Received September 22, 2024

    Report

    Report Number
    9610847-2024-00274
    Event Type
    Malfunction
    Date Received
    September 22, 2024
    Date of Event
    July 31, 2024
    Report Date
    January 27, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    LRS
    UDI-DI
    30382903861720
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE HAS BEEN IDENTIFIED AS A CUSTOMER SERVICE ISSUE AND IS NOT A PRODUCT RELATED ISSUE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD IVSS BLUE IV ACC WO TEGADERM MED GLVS EXPIRED PRODUCT RECEIVED 357.13BX ( (B)(4) EA ) EXPIRED WITH GUARANTEE LETTER. THIS REPORT IS EXPIRED PRODUCT WITH GUARANTEE LETTER ISSUED BY BECTON DICKINSON, THERE ARE 3 LOT NUMBERS WITH THE SAME ARTICLE. THE FOLLOWING ARE THE EXPIRED ITEM WITH CORRESPONDING LOT NUMBER AND QUANTITY : 2278835- (B)(4) EA, 2278838-28,(B)(4) EA, 2278840- (B)(4) EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1525666 BD IVSS BLUE IV ACC WO TEGADERM MED GLVS INTRAVASCULAR CATHETER LRS BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2278840 30382903861720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown