BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8617920 · Received May 16, 2019

    Report

    Report Number
    1710034-2019-00527
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 30, 2019
    Report Date
    June 18, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903835110
    PMA / PMN Number
    K183399
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 THIS BATCH. A ROOT CAUSE COULD NOT BE DETERMINED AND COMPLAINT NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION:

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: G.5. PMA/510(K)#: K183399

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511. BATCH NO.: 8361782. IT WAS REPORTED ONE 24G CATHETER LEAKED AT THE HUB OUT OF THE PATIENT'S SKIN. VERBATIM: ONE 24G CATHETER LEAKED AT HUB OUT OF PATIENTS SKIN CAUSING IV TO BE D/C AND RE-STICK. LOT # 8361782.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511 BATCH NO.: 8361782 IT WAS REPORTED ONE 24G CATHETER LEAKED AT THE HUB OUT OF THE PATIENT'S SKIN. VERBATIM: ONE 24G CATHETER LEAKED AT HUB OUT OF PATIENTS SKIN CAUSING IV TO BE D/C AND RE-STICK. LOT # 8361782.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511 BATCH NO.: 8361782 IT WAS REPORTED ONE 24G CATHETER LEAKED AT THE HUB OUT OF THE PATIENT'S SKIN. VERBATIM: ONE 24G CATHETER LEAKED AT HUB OUT OF PATIENTS SKIN CAUSING IV TO BE D/C AND RE-STICK. LOT # 8361782.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511, BATCH NO.: 8361782. IT WAS REPORTED ONE 24G CATHETER LEAKED AT THE HUB OUT OF THE PATIENT'S SKIN. VERBATIM: ONE 24G CATHETER LEAKED AT HUB OUT OF PATIENTS SKIN CAUSING IV TO BE D/C AND RE-STICK. LOT # 8361782.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408061 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8361782 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 Other