BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT, INTRODUCER FOR PACER

    MDR report key: 903 · Received June 29, 1992

    Report

    Report Number
    1036499-1992-00001
    Event Type
    Malfunction
    Date Received
    June 29, 1992
    Date of Event
    May 14, 1992
    Report Date
    June 10, 1992
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    LUER LOCK HUB FOUND SEPERATED FROM SIDE ARM OF HEMOSTASIS VALVE. NO UNDUE FORCE EXERTED DURING TUBING CHANGE. OCCURANCE TOOK PLACE MAY 14, 1992 NO UNDUE PATIENT COMPLICATIONS NOTEDDEVICE LABELED FOR SINGLE USE. 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.DEVICE WAS EVALUATED AFTER THE 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 PSI KIT, INTRODUCER FOR PACER N/A DQX ARROW INTERNATIONAL, INC. BP-09800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other