BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1647 · Received November 4, 1992

    Report

    Report Number
    1647
    Event Type
    Injury
    Date Received
    November 4, 1992
    Date of Event
    October 26, 1992
    Report Date
    October 27, 1992
    Manufacturer
    UNIVERSAL MEDICAL INSTRUMENT CORPORATION
    Product Code
    EYT
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SHEATH PULLED AS ORDERED BY PHYSICIAN AT 1400. WHEN SHEATH WAS PULLED, HUB OF SHEATH CAME APART FROM THE REST OF THE SHEATH. THE REMAINING CATHETER WAS LEFT STICKING APPROXIMATELY 1/3" OUT OF INSERTION SITE. CATHETER RETREIVED WITH MUCH DIFFICULTY BY GRASPING. PATIENT EXPERIENCE MORE BLOOD LOSS THAN NORMAL WHEN PULLING SHEATHSINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. 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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN UNKNOWN EYT UNIVERSAL MEDICAL INSTRUMENT CORPORATION UNKNOWN 137251

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention