BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PER-Q-CATH 3 FR PICC

    MDR report key: 116564 · Received August 26, 1997

    Report

    Report Number
    1720496-1997-00495
    Event Type
    Injury
    Date Received
    August 26, 1997
    Date of Event
    July 25, 1997
    Report Date
    July 28, 1997
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IMPLICATED IS A 3FR CATHETER WITH GUIDEWIRE. A SECTION OF CATHETER TUBING WHICH MEASURES 49CM WAS RETURNED FOR EVALUATION. LOT HISTORY REVIEW INDICATES NO RELATED COMPONENT OR MFG RELATED ISSUES AND ONE PRODUCT COMPLAINT OF SIMILAR NATURE (ALSO RPT'D BY THIS CUSTOMER) WHICH WAS RECORDED AS INCONCLUSIVE-DUE TO NO PRODUCT RETURNED. THERE IS A LOOSE KNOT TIED IN THE PROXIMAL END OF THE CATHETER TUBING (PRESUMABLY TIED BY THE CLINICIAN TO PREVENT MIGRATION). THE REMAINDER OF THE CATHETER TUBING APPEARS STRAIGHT AND SMOOTH. UNDER TACTILE EXAMINATION THE TUBING IS SEVERELY ELONGATED BETWEEN THE 24 AND 38CM MARKINGS ON THE TUBING. THE KOT WAS REMOVED AND THE TUBING WAS FITTED WITH A BLUNT NEEDLE. THE CATHETER WAS PRESSURIZED WITH A 6CC SYRINGE AND COLORED WATER BY OCCLUDING THE DISTAL END OF THE TUBING WITH A PADDED CLAMP. NO LEAKS WERE DETECTED. THIS WAS REPEATED SEVERAL TIMES WHILE EXERTING PRESSURES ABOVE 40PSI AND THE LUMEN COULD NOT BE MADE TO LEAK. THE LUMEN FLUSHES AND ASPIRATES NORMALLY. THIS COMPLAINT IS INCONCLUSIVE SINCE NO DEFECT COULD BE FOUND WITH THE RETURNED CATHETER TUBING OTHER THAN ELONGATED WHICH PROBABLY OCCURRED DURING ATTEMPTS TO REMOVE THE CATHETER.

    Description of Event or Problem · 1

    THE CATHETER HAD BEEN IN ABOUT 2 WEEKS WHEN THE PATIENT COULD NOT FLUSH IT. UROKINASE WAS UNSUCCESSFULLY TRIED ON THE CATHETER, SO THE NURSE ATTEMPTED TO REMOVE IT. WHEN ALL BUT ABOUT 2" OF THE CATHETER WAS OUT, RESISTANCE WAS MET. HEAT AND REPOSITIONING OF THE ARM WERE TRIED, BUT THE CATHETER WOULD NOT COME OUT. THE CATHETER WAS SURGICALLY REMOVED ON 7//29/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PER-Q-CATH 3 FR PICC Implant LONG TERM INTRAVASCULAR CATHETER DQO BARD ACCESS SYSTEMS 4133100 51FH1571

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention