BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.75 IN

    MDR report key: 9881145 · Received March 25, 2020

    Report

    Report Number
    1710034-2020-00211
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    February 23, 2020
    Report Date
    May 7, 2020
    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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED ONE RETRACTED UNIT IN ITS ORIGINAL OPENED PACKAGING. THROUGH THE VISUAL EXAMINATION OF THE CATHETER AND EXTENSION TUBING ASSEMBLY DAMAGE WAS NOT OBSERVED TO THE UNIT. A LEAK TEST WAS PERFORMED WHERE LEAKAGE WAS NOT OBSERVED. A DAMAGED CATHETER, IMPROPERLY PLACEMENT, OR DISLODGING MAY CAUSE THE INFILTRATION. AS PREVIOUSLY STATED, DAMAGE WAS NOT OBSERVED. WE WERE UNABLE TO CONFIRM THE REPORTED ISSUE. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN THE REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS ¿ SINGLE PORT 24 GA 0.75 IN WERE INVOLVED WITH A SERIOUS INJURY IN THE FORM OF INFILTRATION DURING USE. NO INFORMATION SPECIFYING WHETHER THE INFILTRATION RESULTED IN MEDICAL INTERVENTION/TESTING HAS BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511 BATCH NO.: 9260434 INFILTRATION WAS REPORTED. INCIDENT DATE: (B)(6) 2020. UNKNOWN NUMBER AFFECTED, BUT ACCOUNT DOES HAVE PRODUCT(S) TO BE SENT BACK TO BD FOR INSPECTION.

    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 AN UNSPECIFIED NUMBER OF BD NEXIVA¿ CLOSED IV CATHETER SYSTEMS ¿ SINGLE PORT 24 GA 0.75 IN WERE INVOLVED WITH A SERIOUS INJURY IN THE FORM OF INFILTRATION DURING USE. NO INFORMATION SPECIFYING WHETHER THE INFILTRATION RESULTED IN MEDICAL INTERVENTION/TESTING HAS BEEN PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383511, BATCH NO.: 9260434. INFILTRATION WAS REPORTED. INCIDENT DATE: (B)(6) 2020. UNKNOWN NUMBER AFFECTED, BUT ACCOUNT DOES HAVE PRODUCT(S) TO BE SENT BACK TO BD FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344787 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 24 GA 0.75 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383511 9260434 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other