BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD

    MDR report key: 295100 · Received September 8, 2000

    Report

    Report Number
    MW1019864
    Event Type
    Death
    Date Received
    September 8, 2000
    Date of Event
    August 30, 2000
    Report Date
    August 31, 2000
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM RPTR 5/15/01: PERIPHERAL CATHETER RECOVERED IN RIGHT PULMONARY ARTERY.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM HOSP 9/13/00: SINCE THE TIME THE REPORT WAS FILED, THE PT HAS SINCE DIED. HOSP CONTACTED THE MFR AND INFORMED THEM OF THE INCIDENT. THEY IN TURN INFORMED HOSP THAT THEY HAVE NOT RECEIVED REPORTS OF INCIDENTS INVOLVING THIS OR ANY OTHER LOT NUMBER OF THIS DEVICE (A "PICC LINE"). HOSP HAS NO STOCK REMAINING OF THE AFFECTED LOT NUMBER. THE PRODUCT WAS TEMPORARILY "QUARANTINED" UNTIL HOSP DETERMINED THE LOT NUMBER OF REMAINING STOCK. HOSP HAS USED IT WITHOUT INCIDENT IN THE PAST. SINCE THE MFR INDICATED THEY HAVE NOT RECEIVED INCIDENT REPORTS REGARDING THE DEVICE, AND HOSP HAS NO STOCK REMAINING OF THAT LOT, HOSP RETURNED THE ITEM TO SHELF STOCK.

    Description of Event or Problem · 1

    RECEIVED PHONE CALL FROM HOSPICE RN THAT THEY COULD NOT VISUALIZE THE PICC LINE. PT TRANSPORTED BY AMBULANCE TO HOSP FOR X-RAY OF LEFT UPPER EXTREMITY. NO LINE FOUND. THUS, CHEST X-RAY OBTAINED AND MID-LINE PERIPHERALLY INSERTED CATHETER LOCATED. TRANSFERRED TO TERTIARY HOSP FOR REMOVAL. THE ADAPTERS ARE ALL PATENT AND WERE FOUND STILL SECURED TO THE INDIVIDUAL'S FOREARM AS WERE THE STERI-STRIPS PLACED OVER THE LINE. NO OBVIOUS DEFORMITY TO THE ADAPTERS NOTED. THE END OF THE BLUE ADAPTER (CONNECTOR ASSEMBLY) IS A BIT FLATTENED BUT SHOULDN'T MAKE A DIFFERENCE. ALL ADAPTERS ARE SECURED TIGHTLY THUS, NO IDEA HOW ACTUAL LINE BECAME SEPARATED. ACTUAL PERIPHERALLY INSERTED CATHETER MID-LINE NOT AVAILABLE AS WAS REMOVED AT ANOTHER FACILITY. CONNECTORS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 4FR - GROSHONG SINGLE LUMEN-MID-LINE DQO BARD ACCESS SYSTEMS * 51K12456

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| O| R 1. CADD PUMP FOR ADMINISTRATION OF MORPHINE.