BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25

    MDR report key: 10370943 · Received August 5, 2020

    Report

    Report Number
    3006260740-2020-02780
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 12, 2020
    Report Date
    August 28, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FOZ
    UDI-DI
    00801741110948
    PMA / PMN Number
    K153298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE PRODUCT RETURNED FOR EVALUATION WAS ONE 20GA X 2.25¿ ACCUCATH PERIPHERAL IV CATHETER ASSEMBLY. USE RESIDUES WERE OBSERVED THROUGHOUT THE SAMPLE. THE CATHETER WAS RECEIVED DETACHED FROM THE ASSEMBLY. THE SAFETY BUTTON WAS DEPRESSED AND THE NEEDLE WAS FULLY WITHDRAWN INTO THE HOUSING. THE GUIDEWIRE WAS INTACT. THE CATHETER EXHIBITED ABUNDANT KINKING AND BUCKLING ALONG ITS ENTIRE LENGTH. MICROSCOPIC INSPECTION OF THE CATHETER CONFIRMED ABUNDANT DEFORMATION ALONG THE LENGTH OF THE SHAFT. INSPECTION OF THE TIP REVEALED MINOR DEFORMATION; HOWEVER, THE TIP APPEARED TO HAVE BEEN WELL FORMED. THE EXTENSIVE CATHETER SHAFT BUCKLING AND TIP DEFORMATION WERE CONSISTENT WITH ATTEMPTED ADVANCEMENT AGAINST RESISTANCE, SUCH AS INTO TISSUE. THE BLOOD RESIDUE THROUGHOUT THE DEVICE INDICATED THAT ADVANCEMENT OCCURRED DURING ATTEMPTED DEVICE PLACEMENT. A LOT HISTORY REVIEW (LHR) OF REDZ3030 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE IV TEAM STATED THE ACCUCATH NEEDLES DON'T SEEM AS SHARP AND THE CATHETER IS BUCKLING WHEN TRYING TO ADVANCE. THE CATHETER WAS REMOVED AND ACCESS WAS FOUND IN ANOTHER LOCATION, RESULTING IN ADDITIONAL POKE TO PATIENT. PLACEMENT INFO: ATTEMPTED ULTRASOUND GUIDED PERIPHERAL PLACEMENT IN FOREARM.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND IS PENDING EVALUATION. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REDZ3030 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER HAVE BEEN REPORTED FROM THE SAME FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE IV TEAM STATED THE ACCUCATH NEEDLES DON'T SEEM AS SHARP AND THE CATHETER IS BUCKLING WHEN TRYING TO ADVANCE. THE CATHETER WAS REMOVED AND ACCESS WAS FOUND IN ANOTHER LOCATION, RESULTING IN ADDITIONAL POKE TO PATIENT. PLACEMENT INFO: ATTEMPTED ULTRASOUND GUIDED PERIPHERAL PLACEMENT IN FOREARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830431 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BARD ACCESS SYSTEMS N/A REDZ3030 00801741110948

    Patients

    Seq Age Sex Outcome Treatment
    1