BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV CATHETER SYSTEM SINGLE PORT 18 GA 1.25 IN

    MDR report key: 11466319 · Received March 11, 2021

    Report

    Report Number
    1710034-2021-00183
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 12, 2021
    Report Date
    April 6, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K102520
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY : OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOS SHOWING A USED UNIT WITH TRACES OF THICK MEDIA THROUGHOUT THE UNIT. INSPECTION OF THE PROVIDED PHOTO REVEALED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING NEAR THE TIP, CONFIRMING THE REPORTED DEFECT OF NEEDLE THROUGH CATHETER. THIS TYPE OF DEFECT CAN OCCUR DURING THE MANUFACTURING PROCESS OR IN THE CLINICAL SETTING. THE PRESENCE OF MEDIA THROUGHOUT THE UNIT, INCLUDING THE TIP OF THE CATHETER TUBING, INDICATED THAT THE NEEDLE AND CATHETER WERE CORRECTLY ASSEMBLED AT THE TIME OF VENIPUNCTURE. TYPICALLY, IF THE DEFECT WERE MANUFACTURING RELATED THE USER WOULD NOTICE THE DEFECT BEFORE VENIPUNCTURE AND IF VENIPUNTURE WAS ATTEMPTED IT WOULD HAVE BEEN VERY DIFFICULT, EVEN PAINFUL WITH THE CATHETER TIP FOLDING DURING THE ATTEMPT. BASED ON THIS EVIDENCE, THE ROOT CAUSE IS LIKELY RELATED TO RECANNULATION DURING USE. 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 THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM ¿ SINGLE PORT 18 GA 1.25 IN EXPERIENCED NEEDLE PIERCING THROUGH THE CATHETER DURING INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383519, BATCH NO: 0233429. I AM STILL HEARING A LOT OF CONCERN REGARDING THE FLOW RATES OF THE NEW COMPARED TO THE OLD. WE WERE TOLD THAT THERE WAS NO MAJOR CHANGE, HOWEVER, WE ARE EXPERIENCING THE POWER INJECTORS PRESSURING OUT OR SLOWING DOWN MORE. WE HAVE SOME EXAMS USING OMNIPAQUE 350 THAT NEED TO GO UP TO 6-7 ML/SEC WITH AN 18 GA, BD MAX IS 4.5-5. THEY ARE FEELING A LITTLE ¿TURBULENCE¿ AND HAVE NOTICED ON THE INJECTOR SEEMS TO SLOW DOWN AND THEN SPEED BACK UP. WE WERE NOT ABLE TO GET THE CLEAR CAP ON THE END OF THE TUBING OFF OF AN 18G BD CATHETER (LOT # 0233429). WE HAD TO RE-STICK THE PATIENT WITH ANOTHER 18G. ANOTHER NURSE REPORTED THE NEEDLE GOING THROUGH THE CATH INSIDE THE PATIENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6) HAS BEEN USED AS A DEFAULT.¿ 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 THE BD NEXIVA" CLOSED IV CATHETER SYSTEM  SINGLE PORT 18 GA 1.25 IN EXPERIENCED NEEDLE PIERCING THROUGH THE CATHETER DURING INTRODUCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 383519, BATCH NO: 0233429. I AM STILL HEARING A LOT OF CONCERN REGARDING THE FLOW RATES OF THE NEW COMPARED TO THE OLD. WE WERE TOLD THAT THERE WAS NO MAJOR CHANGE, HOWEVER, WE ARE EXPERIENCING THE POWER INJECTORS PRESSURING OUT OR SLOWING DOWN MORE. WE HAVE SOME EXAMS USING OMNIPAQUE 350 THAT NEED TO GO UP TO 6-7 ML/SEC WITH AN 18 GA, BD MAX IS 4.5-5. THEY ARE FEELING A LITTLE TURBULENCE AND HAVE NOTICED ON THE INJECTOR SEEMS TO SLOW DOWN AND THEN SPEED BACK UP. WE WERE NOT ABLE TO GET THE CLEAR CAP ON THE END OF THE TUBING OFF OF AN 18G BD CATHETER (LOT # 0233429). WE HAD TO RE-STICK THE PATIENT WITH ANOTHER 18G. ANOTHER NURSE REPORTED THE NEEDLE GOING THROUGH THE CATH INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359206 BD NEXIVA CLOSED IV CATHETER SYSTEM SINGLE PORT 18 GA 1.25 IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0233429

    Patients

    Seq Age Sex Outcome Treatment
    1