BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV-SET P 180 CM PVC RLS L-L

    MDR report key: 8356272 · Received February 20, 2019

    Report

    Report Number
    2243072-2019-00296
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Date of Event
    January 22, 2019
    Report Date
    March 1, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER CLARIFYING THERE WAS NO LEAKAGE OF MEDICATION. THIS EVENT IS NO LONGER REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV-SET P 180 CM PVC RLS L-L "CANNOT BE VENTED" AND COULDN'T INFUSE THE "ANTIBIOTICS AND INFUSIONS (E. G. STEROFUNDIN)".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THE REPORTED LOT # [1010728] WAS NOT FOUND FOR THE REPORTED CATALOG # [396353]. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). 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 IV-SET P 180 CM PVC RLS L-L "CANNOT BE VENTED" AND COULDN'T INFUSE THE "ANTIBIOTICS AND INFUSIONS (E. G. STEROFUNDIN)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149363 IV-SET P 180 CM PVC RLS L-L INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other