BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA KIT W/ Q-SYTE 22GA 1.0IN

    MDR report key: 11312047 · Received February 10, 2021

    Report

    Report Number
    9610847-2021-00062
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    January 14, 2021
    Report Date
    March 5, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A COMPLAINT OF FOREIGN MATTER WAS RECEIVED FROM THE CUSTOMER. A SAMPLE WAS RETURNED TO AID IN THE INVESTIGATION. THROUGH VISUAL INSPECTION FOREIGN MATTER WAS CONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 2011252. 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. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #2011252 REGARDING ITEM #383652.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ KIT W/ Q-SYTE¿ 22GA 1.0IN EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAIR WAS FOUND IN A PACKAGE OF Q-SYTE (385100), WHICH IS A COMPONENT OF NEXIVA (383652). LOT # OF Q-SYTE (385100) IS REPORTED TO BE 2011252.

    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. DEVICE EXPIRATION DATE: UNKNOWN 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 BD NEXIVA¿ KIT W/ Q-SYTE¿ 22GA 1.0IN EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE/SEAL WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAIR WAS FOUND IN A PACKAGE OF Q-SYTE (385100), WHICH IS A COMPONENT OF NEXIVA (383652). LOT # OF Q-SYTE (385100) IS REPORTED TO BE 2011252.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206916 BD NEXIVA KIT W/ Q-SYTE 22GA 1.0IN INTERVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2011252

    Patients

    Seq Age Sex Outcome Treatment
    1