BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER INTROSYTE-N 1.9F 1.9CM

    MDR report key: 12636537 · Received October 14, 2021

    Report

    Report Number
    1710034-2021-00886
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    July 29, 2021
    Report Date
    October 25, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    DYB
    UDI-DI
    00382903840212
    PMA / PMN Number
    K020834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO PHOTOS OR 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. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTRODUCER INTROSYTE-N 1.9F 1.9CM SHEATH BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NNP SLID INTRODUCER CATHETER OUT AND WENT TO PEEL IT AWAY. NNP GRABBED THE PURPLE WINGS TO SNAP AND PEEL AWAY AND ONE OF THE PURPLE WINGS COMPLETELY BROKE OFF BEFORE THE PEELING COULD BE COMPLETED.   VERBATIM: DESCRIBE THE EVENT OR PROBLEM: NEONATAL NURSE PRACTITIONER (NNP) PLACED A PICC LINE INTO PATIENT USING INTROSYTE-N INTRODUCER. AFTER VEIN WAS ACCESSED, THE NEEDLE WAS MOVED AND PICC CATHETER ADVANCED WITHOUT DIFFICULTY. NNP SLID INTRODUCER CATHETER OUT AND WENT TO PEEL IT AWAY. NNP GRABBED THE PURPLE WINGS TO SNAP AND PEEL AWAY AND ONE OF THE PURPLE WINGS COMPLETELY BROKE OFF BEFORE THE PEELING COULD BE COMPLETED. SO THERE WAS NO WAY TO CONTINUE TO REMOVE THE PEEL AWAY CATHETER. NNP HAD TO HAVE ANOTHER NNP SCRUB IN TO HOLD PICC CATHETER IN PLACE WHILE TWEEZERS WERE USED TO SLOWLY PICK OFF THE REST OF THE PEEL AWAY CATHETER. THIS WAS SUCCESSFUL AND NO HARM OCCURRED.

    Additional Manufacturer Narrative · 1

    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 INTRODUCER INTROSYTE-N 1.9F 1.9CM SHEATH BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT NNP SLID INTRODUCER CATHETER OUT AND WENT TO PEEL IT AWAY. NNP GRABBED THE PURPLE WINGS TO SNAP AND PEEL AWAY AND ONE OF THE PURPLE WINGS COMPLETELY BROKE OFF BEFORE THE PEELING COULD BE COMPLETED.   VERBATIM: DESCRIBE THE EVENT OR PROBLEM: NEONATAL NURSE PRACTITIONER (NNP) PLACED A PICC LINE INTO PATIENT USING INTROSYTE-N INTRODUCER. AFTER VEIN WAS ACCESSED, THE NEEDLE WAS MOVED AND PICC CATHETER ADVANCED WITHOUT DIFFICULTY. NNP SLID INTRODUCER CATHETER OUT AND WENT TO PEEL IT AWAY. NNP GRABBED THE PURPLE WINGS TO SNAP AND PEEL AWAY AND ONE OF THE PURPLE WINGS COMPLETELY BROKE OFF BEFORE THE PEELING COULD BE COMPLETED. SO THERE WAS NO WAY TO CONTINUE TO REMOVE THE PEEL AWAY CATHETER. NNP HAD TO HAVE ANOTHER NNP SCRUB IN TO HOLD PICC CATHETER IN PLACE WHILE TWEEZERS WERE USED TO SLOWLY PICK OFF THE REST OF THE PEEL AWAY CATHETER. THIS WAS SUCCESSFUL AND NO HARM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529844 INTRODUCER INTROSYTE-N 1.9F 1.9CM CATHETER INTRODUCER DYB BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 1005635 00382903840212

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Male