BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOCATH-T

    MDR report key: 335421 · Received May 24, 2001

    Report

    Report Number
    9610175-2001-00012
    Event Type
    Malfunction
    Date Received
    May 24, 2001
    Date of Event
    April 12, 2001
    Report Date
    April 25, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GCB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM ABBOTT INTERNATIONAL (ABBOTT-TURKEY) WHICH STATES "THE PATIENT HAS BEEN IMPLEMENTED WITH THE ABBOCATH-T 22 GAUGE FOR BLOOD TRANSFUSION. DURING THE TRANSFUSION THE PVC PART AND THE PVC PART OF THE CATHETER HAS SEPARATED FROM THE CONNECTION PART AND THE PVC PART OF THE CATHETER HAD STAYED IN THE VEIN. A SURGEON, WHO WAS ON CALL, REMOVED THE PVC PART WITH MINOR SURGICAL PROCEDURE. THE PT HAS BEEN DISCHARGED." ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED, BUT NO FURTHER INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    ADD'L INFO RECEIVED FROM ABBOTT INT'L (ABBOTT-TURKEY) STATES "THE PT WAS HOSPITALIZED ON 4/11/01. THE NEXT DAY THE ABBOCATH HAD BEEN PLACED BY A NURSE. ONE UNIT OF SCAVENGED BLOOD HAD BEEN TRANSFUSED. THE BLOOD TRANSFUSION HAD BEEN COMPLETED WITHOUT ANY COMPLICATION (NO DELAY BECAUSE OF THE SEPARATION). DURING THE EVENING THE PT HAD CALLED THE NURSE AND THE PHYSICIAN, WHO WERE ON CALL AND HAD STATED THAT PVC PART OF THE CATHETER STAYED IN HER VEIN WHILE SHE WAS SLEEPING. ACCORDING TO PHYSCIAN'S STATEMENT, THE CATHETER WAS SEPARATED BETWEEN PVC PART AND THE HUB. THERE WAS NOT ANY OF THE CANNULA STILL ATTACHED TO THE HUB. THE ABBOCATH HAD BEEN USED APPROXIMATELY 12-15 HRS BEFORE THE SEPARATION OCCURRED. THERE WAS NO LEAKAGE BEFORE THE SEPARATION. AFTER THEY REMOVED THE CANNULA THEY CONTINUED THE THERAPY. THE PT HAD BEEN DISCHARGED WITHOUT ANY COMPLICATION. THERE IS NO INFO WHETHER ANOTHER ABBOCATH HAD BEEN PLACED OR NOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24887 ABBOCATH-T CANNULA GCB ABBOTT LABORATORIES NA 51-919-VM

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention