BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DOUBLE AIR HOSE SCHRADER STEM

    MDR report key: 3812381 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11355
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 18, 2014
    Manufacturer
    NI
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE FACILITY WAS UNAVAILABLE. THE PMA/510(K) NUMBER WAS UNAVAILABLE. THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND OBSERVED THAT THE INNER HOSE WAS DAMAGED. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE ROOT CAUSE WAS DETERMINED TO BE DUE TO NORMAL USE OVER TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE DOUBLE AIR HOSE STEM DEVICE HAD AN "AIR LEAK." THE REPORTER FURTHER CLARIFIED THAT WHEN THE NITROGEN WAS TURNED ON, THE PLASTIC PART OF THE HOSE WOULD INFLATE. THERE WAS NO DELAY TO THE SCHEDULED SURGICAL PROCEDURE. AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF PATIENT OR USER INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291982 DOUBLE AIR HOSE SCHRADER STEM MOTOR, DRILL, PNEUMATIC HBB NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1