BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8950632 · Received August 30, 2019

    Report

    Report Number
    1710034-2019-00949
    Event Type
    Injury
    Date Received
    August 30, 2019
    Date of Event
    August 12, 2019
    Report Date
    October 22, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE USED NEXIVA 24GA UNIT IN AN OPENED PACKAGE FROM MATERIAL NUMBER 383511, LOT NUMBER 9135958 WITH AN ATTACHED NEEDLE FREE CONNECTOR. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. THE TRANSPARENT DRESSING WAS REMOVED. VISUAL/MICROSCOPIC EVALUATION WAS PERFORMED AND THERE WERE NO SIGNS OF HOLES, SPLITS, KINKS, WRINKLES OR BALLOONED EXTENSION TUBING. THERE WAS DAMAGE TO THE OUTSIDE BODY OF THE STRAIGHT ADAPTER. A WATER/AIR LEAK TEST WAS PERFORMED WITH THE ATTACHED NEEDLE FREE CONNECTOR AND AIR BUBBLES WERE OBSERVED COMING FROM THE CONNECTION SITE BETWEEN THE STRAIGHT ADAPTER AND THE NEEDLE FREE CONNECTOR. CONCLUSION: INDETERMINATE- ALTHOUGH THE RETURNED UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, PER THE PIR. DAMAGED TO THE STRAIGHT ADAPTER WAS OBSERVED; WHICH DID LEAK DURING THE WATER/AIR LEAK TEST. THE ROOT CAUSED WOULD BE MANUFACTURING. THE DAMAGE TO THE ADAPTER WAS CAUSED BY THE OFF-LOAD GRIPPERS USED TO REMOVE THE PART FROM THE SUPER TRACK PALLET TO THE BOSCH PALLET ON ZONE 8, STATION 55. HOWEVER, THE EXACT CONDITIONS THAT CAUSED THE DAMAGE HAVE NOT BEEN ABLE TO BE REPRODUCED. WE HAVE NOT EXPERIENCED THIS TYPE OF DEFECT AT A HIGH ENOUGH RATE TO HAVE EVER SEEN IT DURING PRODUCTION. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WAS FLUSHED WITH SALINE DURING USE WHEN A HOLE WAS FOUND IN THE EXTENSION TUBING. A "SPRAY OF BLOOD" SPLASHED THE NURSE, MAKING CONTACT WITH THE EYE. THE FACE WAS WIPED AND THE EYE FLUSHED/IRRIGATED WITH "500MLS" OF SALINE, AND THE INCIDENT REPORTED TO OCCUPATIONAL HEALTH. ADDITIONALLY, THE PATIENT HAD TO BE RE-CANNULATED, WITH "SOME DELAY IN TREATMENT DELIVERY." THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOLLOWING INSERTION OF NEXIVA, NURSE FLUSHED THE EXTENSION TUBING WITH SALINE AND A HOLE WAS OBSERVED IN THE EXTENSION TUBING AND THE NURSE EXPERIENCED A SPRAY OF BLOOD." PATIENT WAS RE-CANNULATED AND TREATMENT CONTINUED AS PLANNED, SOME DELAY IN TREATMENT DELIVERY THOUGH. BLOOD SPLASH. RCC: I WILL ASK IF TO THE MUCOSAL MEMBRANES. UPDATE: YES - EYE. FACE WIPED AND EYE FLUSHED/IRRIGATED WITH 500MLS OF SALINE. REPORTED TO OCCUPATIONAL HEALTH.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 WAS FLUSHED WITH SALINE DURING USE WHEN A HOLE WAS FOUND IN THE EXTENSION TUBING. A "SPRAY OF BLOOD" SPLASHED THE NURSE, MAKING CONTACT WITH THE EYE. THE FACE WAS WIPED AND THE EYE FLUSHED/IRRIGATED WITH "500MLS" OF SALINE, AND THE INCIDENT REPORTED TO OCCUPATIONAL HEALTH. ADDITIONALLY, THE PATIENT HAD TO BE RE-CANNULATED, WITH "SOME DELAY IN TREATMENT DELIVERY". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOLLOWING INSERTION OF NEXIVA, NURSE FLUSHED THE EXTENSION TUBING WITH SALINE AND A HOLE WAS OBSERVED IN THE EXTENSION TUBING AND THE NURSE EXPERIENCED A SPRAY OF BLOOD." PATIENT WAS RE-CANNULATED AND TREATMENT CONTINUED AS PLANNED, SOME DELAY IN TREATMENT DELIVERY THOUGH. BLOOD SPLASH. RCC: I WILL ASK IF TO THE MUCOSAL MEMBRANES UPDATE: YES - EYE FACE WIPED AND EYE FLUSHED/ IRRIGATED WITH 500MLS OF SALINE. REPORTED TO OCCUPATIONAL HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746336 BD NEXIVA¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9135958 30382903835110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention