BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS LVP 20D 3SS CV

    MDR report key: 11943494 · Received June 4, 2021

    Report

    Report Number
    2243072-2021-01617
    Event Type
    Malfunction
    Date Received
    June 4, 2021
    Date of Event
    May 7, 2021
    Report Date
    August 31, 2021
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: SITE LEGAL NAME (FDA): TIJUANA B.5. DESCRIBE EVENT OR PROBLEM: THE EVENT DESCRIPTION HAS BEEN UPDATED WITH A NEW MEDICAL DEVICE BRAND NAME. D.1. MEDICAL DEVICE BRAND NAME: AS LVP 20D 3SS CV D.3. MEDICAL DEVICE MANUFACTURER: TIJUANA D.2. MEDICAL DEVICE CATALOG #: 2426-0007 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: TIJUANA. G.5. PMA/510(K)#: K944320.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-24 H6: INVESTIGATION SUMMARY ONE SAMPLE WAS RETURNED FOR INVESTIGATION BY THE CUSTOMER. THE SAMPLE WAS INVESTIGATION AND FOUND THAT THE PROBABLE CAUSE OF THE CUSTOMER¿S PERCEPTION OF AN OVER INFUSION WAS BELIEVED TO BE DUE TO THE DISPOSABLE SET BACKFLOW FROM THE SECONDARY TO THE PRIMARY IV BAG. A QUALITY NOTIFICATION HAS BEEN SENT TO THE SUPPLIER, AND THE SAMPLE HAS BEEN SENT FOR FURTHER INVESTIGATION. THE SUPPLIER DETERMINED THE ROOT CAUSE TO BE PARTICULATE MATTER FOUND IN THE DEVICE. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS OVERINFUSION WHILE USING AS LVP 20D 3SS CV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS AN OVER-INFUSION CONCERN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS OVERINFUSION WHILE USING AS LVP 20D 3SS CV. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS AN OVER-INFUSION CONCERN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: 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) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERINFUSION WHILE USING UNSPECIFIED BD¿ TUBING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS AN OVER-INFUSION CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838791 AS LVP 20D 3SS CV INTRAVASCULAR ADMINISTRATION SET FPA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1