BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHALLY INSERTED CENTRAL CATHETER (PICC)

    MDR report key: 4445 · Received July 2, 1992

    Report

    Report Number
    4445
    Event Type
    Injury
    Date Received
    July 2, 1992
    Date of Event
    February 19, 1992
    Report Date
    July 1, 1992
    Manufacturer
    HDC CORPORATION
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    V-CATH IN PLACE. PATIENT BEGAN TO EXPERIENCE REDNESS AND SWELLING. CATH COULD ONLY BE REMOVED SHORT DISTANCE DUE TO VEIN SPASM. TAPED IN POSITION FOR FURTHER REMOVAL NEXT DAY. CATHETER WOULD NOT MOVE - BROKE UP IN ATTEMPT. PATIENT TAKEN TO FLUOROSCOPY FOR REMOVAL. NO ADVERSE CONSEQUENCESINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHALLY INSERTED CENTRAL CATHETER (PICC) DQO HDC CORPORATION 044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention