BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV START PAK W/PERSIST, TEGADERM

    MDR report key: 11402985 · Received March 3, 2021

    Report

    Report Number
    9610847-2021-00089
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 4, 2021
    Report Date
    March 30, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A COMPLAINT OF PRODUCT SPILLING WAS RECEIVED FROM THE CUSTOMER. A PHOTO WAS PROVIDED TO AID IN THE INVESTIGATION OF THIS DEFECT. THROUGH VISUAL INSPECTION THE CUSTOMER COMPLAINT WAS CONFIRMED. IT WAS OBSERVED THAT THE PERSIST SPILLED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0092928. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. A ROOT CAUSE COULD NOT BE DETERMINED BECAUSE A SAMPLE WAS NOT RETURNED FOR INVESTIGATION. THIS IS THE FIRST COMPLAINT FOR PRODUCT SPILL ON MATERIAL 394910 & BATCH 0092928. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV START PAK W/PERSIST, TEGADERM EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT SPILL. MATERIAL: 386170. LOT: 0092928. QUANTITY: 1 EA.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IV START PAK W/PERSIST, TEGADERM EXPERIENCED DAMAGED OR OPEN UNIT PACKAGING/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT SPILL. MATERIAL: 386170. LOT: 0092928. QUANTITY: 1 EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304800 IV START PAK W/PERSIST, TEGADERM INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 0092928

    Patients

    Seq Age Sex Outcome Treatment
    1