BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75"

    MDR report key: 14242189 · Received April 28, 2022

    Report

    Report Number
    1710034-2022-00222
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 8, 2022
    Report Date
    May 5, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835318
    PMA / PMN Number
    K183399
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. LOT NUMBER WAS NOT REPORTED; HOWEVER, A POTENTIAL LOT NUMBER WAS PROVIDED. THE INFORMATION FOR THAT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #:1155068. MEDICAL DEVICE EXPIRATION DATE:31MAY2024. DEVICE MANUFACTURE DATE:04APR2021. MEDICAL DEVICE LOT #:1091027. MEDICAL DEVICE EXPIRATION DATE:31MAR2024. DEVICE MANUFACTURE DATE:01APR2021. MEDICAL DEVICE LOT #:1091940. MEDICAL DEVICE EXPIRATION DATE:31MAR2024. DEVICE MANUFACTURE DATE:01APR2021. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBERS. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75" FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT DIRT INSIDE THE NEEDLE COVER OF NEXIVA. ACCORDING TO THE CUSTOMER'S REPORT, DIRT WAS FOUND INSIDE THE NEEDLE COVER OF NEXIVA AFTER UNPACKING BEFORE USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75" FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT DIRT INSIDE THE NEEDLE COVER OF NEXIVA. ACCORDING TO THE CUSTOMER'S REPORT, DIRT WAS FOUND INSIDE THE NEEDLE COVER OF NEXIVA AFTER UNPACKING BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213114 BD NEXIVA DUAL PORT WITH Q-SYTE, 24G X 0.75" INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383531 UNKNOWN 30382903835318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown