BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ IV CATHETER

    MDR report key: 16185966 · Received January 17, 2023

    Report

    Report Number
    8041187-2022-00812
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    December 6, 2022
    Report Date
    February 28, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903813117
    PMA / PMN Number
    K151698
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2021235. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027. DEVICE MANUFACTURE DATE: 20-MAY-2022. MEDICAL DEVICE LOT #: 2140686. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. DEVICE MANUFACTURE DATE: 21-JAN-2022. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS AND 2 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUES OF NEEDLE THROUGH CATHETER WERE CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THE NEEDLE PIERCED THROUGH THE CATHETER NEAR THE TIP AREA AND THE CANNULA TIP POINT WAS DAMAGED. BD COULD NOT CONFIRM A MANUFACTURING RELATED ROOT CAUSE SINCE THE SAMPLES WERE ALL REJECTED BY OUR IN-LINE VISION SYSTEMS WHICH SERVE TO REJECT FAULTY PRODUCTS FORM THE PRODUCTION LINE. OUR INVESTIGATION RESULTS SHOW THAT THESE SAMPLES WOULD HAVE BEEN AUTOMATICALLY REJECTED IF THE FAILURE OCCURRED DURING PRODUCTION. THERE IS A POSSIBILITY THE FAILURE COULD HAVE BEEN CAUSED DURING HANDLING OR TRANSPORTATION WITHOUT THE PROTECTION OF NEEDLE COVER. SINCE THE SAMPLES WERE RETURNED WITH DETACHED NEEDLE COVER AND IN OPEN PACKAGING A USE RELATED ROOT CAUSE CANNOT BE DETERMINED. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSYTE-N¿ IV CATHETER EACH FROM LOTS 2021235 AND 2140686 HAD ISSUES WITH THE NEEDLE PIERCING THROUGH CATHETER UPON INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "ATTEMPT TO INSERT A PERIPHERAL VENOUS LINE (VVP) ON A NEW 15 DAY OLD. WHEN CHECKING THE SLIDING OF THE TROCAR IN THE PLASTIC CASE OF THE VVP, THE TROCAR PIERCES THE PLASTIC CASE AT THE END. ALSO, SLIDING/INSERTING THE TROCAR INTO THE VVP IS NOT EASY AS THE PLASTIC EDGE OF THE NEEDLE TENDS TO HIT THE ENTRANCE OF THE VVP. CLINICAL CONSEQUENCES: LOSS OF TIME, STRESS FOR STAFF AND THE SURROUNDING FAMILY, CRYING OF THE BABY, RISK OF DAMAGING THE VEIN. PRECAUTIONARY MEASURES: CHANGE OF CATHETER".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSYTE-N¿ IV CATHETER EACH FROM LOTS 2021235 AND 2140686 HAD ISSUES WITH THE NEEDLE PIERCING THROUGH CATHETER UPON INSERTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "ATTEMPT TO INSERT A PERIPHERAL VENOUS LINE (VVP) ON A NEW 15 DAY OLD. WHEN CHECKING THE SLIDING OF THE TROCAR IN THE PLASTIC CASE OF THE VVP, THE TROCAR PIERCES THE PLASTIC CASE AT THE END... ALSO, SLIDING/INSERTING THE TROCAR INTO THE VVP IS NOT EASY AS THE PLASTIC EDGE OF THE NEEDLE TENDS TO HIT THE ENTRANCE OF THE VVP. CLINICAL CONSEQUENCES: LOSS OF TIME, STRESS FOR STAFF AND THE SURROUNDING FAMILY, CRYING OF THE BABY, RISK OF DAMAGING THE VEIN PRECAUTIONARY MEASURES: CHANGE OF CATHETER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655756 BD INSYTE-N¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10 00382903813117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown