BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS

    MDR report key: 5807261 · Received July 19, 2016

    Report

    Report Number
    3006260740-2016-00362
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    February 7, 2016
    Report Date
    July 7, 2016
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741051890
    PMA / PMN Number
    0600600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD.

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF HUXI0984 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT A CHILD PATIENT HAD A 9FR HICKMAN CATHETER IN FOR 19 DAYS BEFORE THE CATHETER REPORTEDLY BROKE ¿SPONTANEOUSLY¿ BETWEEN THE INSERTION AND Y BIFURCATION. THE PATIENT WAS RECEIVING IMMUNOSUPPRESSANT AND SEDATION CONTINUOUSLY BY INFUSION PUMP THROUGH THE WHITE LINE ¿VIA NPP¿. THE RED LINE WAS BEING USED FOR OTHER IV MEDICATIONS AND TRANSFUSION OF BLOOD COMPONENTS INTERMITTENTLY. COMPATIBILITIES WERE STUDIED BY CLINICAL PHARMACIST FLOOR. FACILITY STATED THAT THERE WERE REPORTS OF ALARM ON THE INFUSION PUMP BY THE NURSING TEAM DUE TO ALLEGED BLOCKING. THIS WAS NOTED ABOUT TWO DAYS BEFORE THE EVENT; HOWEVER, FLUSHING WAS PERFORMED AND NO RESISTANCE WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460907 HICKMAN 9 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TIS PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS HUXI0984 00801741051890

    Patients

    Seq Age Sex Outcome Treatment
    1