BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JOL CATHETER AND TIP, SUCTION

    MDR report key: 10251777 · Received July 9, 2020

    Report

    Report Number
    1820334-2020-01279
    Event Type
    Malfunction
    Date Received
    July 9, 2020
    Date of Event
    June 24, 2020
    Report Date
    August 6, 2020
    Manufacturer
    COOK INC
    Product Code
    JOL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. CORRECTION: B5 THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DURING THE INVESTIGATION, IT WAS DETERMINED THIS EVENT WAS INADVERTENTLY REPORTED AS IT DOES NOT MEET REPORTING CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: UNKNOWN. PMA/510(K) #: EXEMPT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDE WIRE OF A WAYNE PNEUMOTHORAX SET WAS BENT AND UNABLE TO COME BACK THROUGH THE TIP OF THE INTRODUCER. THE TROCAR WAS UNABLE TO PROGRESS OVER THE WIRE GUIDE FOR INSERTION. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715697 JOL CATHETER AND TIP, SUCTION JOL COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1