BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 7390632 · Received April 2, 2018

    Report

    Report Number
    8020889-2018-00042
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    March 23, 2018
    Report Date
    June 18, 2018
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K771219. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: ONE SAMPLE WAS RETURNED FOR EVALUATION CONTAINED IN A PLASTIC BAG WITH ITS ORIGINAL OPENED UNIT PACK. VISUAL EXAMINATION SHOWS THAT THE SHAPE OF THE TUBING HAS BEEN ALTERED USING THE STYLET WIRE AND THE TRACHEAL CUFF IS STRETCHED OVER THE TRACHEAL CUFF NOTCH. THE STYLET WIRE WAS REMOVED FROM THE TUBING AND AIR WAS REMOVED FROM THE TRACHEAL CUFF. THE RETURNED UNIT WAS INFLATED AND LEAK TESTED UNDER WATER. NO LEAKAGE WAS DETECTED. THE RETURNED UNIT REMAINED INFLATED AND NO LEAKAGE WAS DETECTED. THE REPORTED DEFECT COULD NOT BE DETECTED ON THE UNIT RETURNED FOR EVALUATION. WE WOULD LIKE TO DRAW YOUR ATTENTION TO OUR ¿INSTRUCTIONS FOR USE¿ (IFU) UNDER THE SECTION ¿WARNINGS / PRECAUTION (CUFF-RELATED)¿ WHERE IT STATES ¿SYRINGES, THREE-WAY STOPCOCKS OR OTHER LUER TIP DEVICES SHOULD NOT BE LEFT INSERTED IN THE INFLATION VALVES FOR EXTENDED PERIODS OF TIME¿. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE DEVICE HAD AN AIRBAG LEAKAGE. CUSTOMER INDICATED THAT THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT PERMANENT IMPAIRMENT OF A FUNCTION, THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232735 MALLINCKRODT TUBE, BRONCHIAL (W/WO CONNECTOR) BTS MALLINCKRODT MEDICAL 126-37 201704097X

    Patients

    Seq Age Sex Outcome Treatment
    1