BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV START PAK W/PERSIST, TEGADERM

    MDR report key: 9489586 · Received December 18, 2019

    Report

    Report Number
    9610847-2019-00749
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    December 3, 2019
    Report Date
    February 19, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    LRS
    UDI-DI
    30382903861706
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9151991. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS AND ALL INSPECTIONS WERE FOUND TO BE WITHIN SPECIFICATION. TO FURTHER INVESTIGATE THIS INCIDENT, TWO PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, IT APPEARS THAT THE LEAKAGE WAS COMING FROM THE PERSIST PACKAGE. THROUGH EXAMINATION OF THE PICTURE, FURTHER DAMAGE COULD NOT IDENTIFIED AND THEREFORE, THE COMPLAINT OF BROKEN PRODUCT COULD NOT BE SUBSTANTIATED. DURING THE MANUFACTURING PROCESS, THE BD PERSIST SINGLE PACKAGE IS INSPECTED FOR SIGNS OF DAMAGE. AT THIS TIME, A MANUFACTURING RELATED CAUSE FOR THIS ISSUE CANNOT BE DETERMINED. A NOTIFICATION HAS BEEN SEND TO THE SUPPLIERS AFFILIATED WITH THIS PRODUCT TO FURTHER INVESTIGATE THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IV START PAK W/PERSIST, TEGADERM CAME BROKEN AND HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMES BROKEN AND STAINED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IV START PAK W/PERSIST, TEGADERM CAME BROKEN AND HAD FOREIGN MATTER ON IT. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMES BROKEN AND STAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286682 IV START PAK W/PERSIST, TEGADERM N/A LRS BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 386170 9151991 30382903861706

    Patients

    Seq Age Sex Outcome Treatment
    1 Other