BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8405993 · Received March 8, 2019

    Report

    Report Number
    1710034-2019-00273
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    February 12, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT. NO PHYSICAL SAMPLES WERE RECEIVED FOR TESTING AND EVALUATION; ONE PHOTO WAS PROVIDED FOR EVALUATION OF THIS INCIDENT. PHOTO DISPLAYED TWO PACKAGE LABELS WHICH REVEALED THE BD LOGO, REF NO., DESCRIPTION, LOT NUMBER AND THE EXPIRATION DATE. VISUAL/MICROSCOPIC EVALUATION: BASED ON THE REVIEW OF THE SUBMITTED PHOTO THE DEFECTS CATHETER KINKED/BENT AND NEEDLE PENETRATION DIFFICULT/PAINFUL WAS NOT IDENTIFIED OR CONFIRMED. THE PHOTO WAS OF TWO PACKAGE LABELS. WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER MADE A PUNCTURE SITE LARGER THAN THE CATHETER REMAINING IN PATIENT CAUSING A BACK FLOW OF BLOOD UNDER THE TEGADERM. NURSES ALSO REPORTED THE FOLLOWING, "IT WAS REPORTED THE NEEDLE WAS BENT AND WOULD NOT ADVANCE. "THERE STILL HAS NOT BEEN ANY FOLLOW UP TO THE ISSUES WE ARE EXPERIENCING WITH THE 22G ANGIOCATHS WE FIRST REPORTED AT THE END OF JANUARY. WE NEED SOME RESOLUTION TO THIS ASAP. BELOW I HAVE ATTACHED THE PICTURE OF THE OLD AUTOGUARD 22G THAT WE DID NOT HAVE ANY ISSUES WITH VS. THE NW 22G AUTOGUARD THAT IS LEAKING AND CAUSING PATIENT SAFETY ISSUES." "RANDOM CATHETERS MADE A PUNCTURE SITE LARGER THAN THE CATHETER REMAINING IN PATIENT CAUSING A BACK FLOW OF BLOOD UNDER THE TEGADERM." "ACCORDING TO OUR EVENT REPORTING SYSTEM BOTH OF THE EVENTS OCCURRED ON (B)(6) 2019. BELOW IS WHAT HOW THE STAFF MEMBERS DESCRIBED THE INCIDENTS. BD INSYTE AUTOGUARD CATHETER. DIFFICULTY ADVANCING CATHETER. NURSE RECEIVED FLASH WHEN INSERTING IV BUT UNABLE TO ADVANCE CATHETER. PRODUCT IS FLIMSY AND UNABLE TO ADVANCE INTO THE VEIN BD INSYTE AUTOGUARD IV CATHETER LOT #8220859. ISSUE WITH ADVANCING THE CATHETER. UPON INSERTION NURSE RECEIVED FLASH AND WAS VISIBLY IN THE VEIN, HOWEVER CATHETER WAS UNABLE TO ADVANCE INTO THE VEIN. CATHETER IS FLIMSY AND BENDS WHEN ATTEMPTS TO ADVANCE ARE MADE."

    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 A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER MADE A PUNCTURE SITE LARGER THAN THE CATHETER REMAINING IN PATIENT CAUSING A BACK FLOW OF BLOOD UNDER THE TEGADERM. NURSES ALSO REPORTED THE FOLLOWING, "IT WAS REPORTED THE NEEDLE WAS BENT AND WOULD NOT ADVANCE." "THERE STILL HAS NOT BEEN ANY FOLLOW UP TO THE ISSUES WE ARE EXPERIENCING WITH THE 22G ANGIOCATHS WE FIRST REPORTED AT THE END OF JANUARY. WE NEED SOME RESOLUTION TO THIS ASAP. BELOW I HAVE ATTACHED THE PICTURE OF THE OLD AUTOGUARD 22G THAT WE DID NOT HAVE ANY ISSUES WITH VS. THE NW 22G AUTOGUARD THAT IS LEAKING AND CAUSING PATIENT SAFETY ISSUES." "RANDOM CATHETERS MADE A PUNCTURE SITE LARGER THAN THE CATHETER REMAINING IN PATIENT CAUSING A BACK FLOW OF BLOOD UNDER THE TEGADERM." "ACCORDING TO OUR EVENT REPORTING SYSTEM BOTH OF THE EVENTS OCCURRED ON (B)(6) 2019. BELOW IS WHAT HOW THE STAFF MEMBERS DESCRIBED THE INCIDENTS. BD INSYTE AUTOGUARD CATHETER. DIFFICULTY ADVANCING CATHETER. NURSE RECEIVED FLASH WHEN INSERTING IV BUT UNABLE TO ADVANCE CATHETER. PRODUCT IS FLIMSY AND UNABLE TO ADVANCE INTO THE VEIN BD INSYTE AUTOGUARD IV CATHETER LOT #8220859. ISSUE WITH ADVANCING THE CATHETER. UPON INSERTION NURSE RECEIVED FLASH AND WAS VISIBLY IN THE VEIN, HOWEVER CATHETER WAS UNABLE TO ADVANCE INTO THE VEIN. CATHETER IS FLIMSY AND BENDS WHEN ATTEMPTS TO ADVANCE ARE MADE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196169 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8220859 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other