BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DALE TRACHEOSTOMY TUBE HOLDER

    MDR report key: 14013385 · Received April 5, 2022

    Report

    Report Number
    1214422-2022-00002
    Event Type
    Malfunction
    Date Received
    April 5, 2022
    Date of Event
    December 26, 2021
    Report Date
    January 25, 2022
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    UDI-DI
    00817612020667
    PMA / PMN Number
    LISTING ONLY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED ON (B)(6) 2021, AN ADOLESCENT PATIENT WITH A TRACHEOSTOMY TUBE AND MECHANICAL VENTILATION, THE VELCRO PART OF THE TRACH HOLDER / STRAP WAS FOUND TO BE COMPLETELY DETACHED / BROKEN OFF FROM THE SOFT PART OF THE STRAP THAT ENCIRCLES THE NECK. TRACH HOLDER / STRAP WAS REPLACED UPON DISCOVERY OF BREAKAGE. NO PATIENT HARM WAS REPORTED. ON THE SAME DAY, WE RECEIVED A SECOND REPORT OF ANOTHER ISSUE OF AN ADOLESCENT PATIENT WITH A TRACHEOSTOMY TUBE AND MECHANICAL VENTILATION, BUT ON (B)(6) 2021. WE CONTACTED THE INITIAL REPORTER TO GET ADDITIONAL INFORMATION ABOUT BOTH EVENTS AND THE DEVICES: THE INITIAL REPORTER CONFIRMED THAT BOTH REPORTS WERE RELATIVE TO THE SAME PATIENT. THE INITIAL REPORTER CONFIRMED THAT THE FACILITY DID NOT RETAIN ANY OF THE BROKEN DEVICES FOR MANUFACTURER REVIEW AND THE LOT NUMBERS FOR THE (B)(6) 2021 EVENT WERE UNKNOWN, BUT THE LOT NUMBER FOR THE (B)(6) 2021 EVENT IS 21H2318. THE INITIAL REPORTER COULD NOT CONFIRM IF THE (VELCRO) TABS HAD BROKEN OR IF THEY HAD COME UNSEWN FROM THE NECK STRAP. THE INITIAL REPORTER CONFIRMED THAT SHE DID CHECK WITH OTHER DEPARTMENTS AT (B)(6) THAT USES THE DALE 240 DEVICE TO SEE IF THERE WERE ANY OTHER ISSUES NOTED AND THERE WERE NOT. DALE MEDICAL PERFORMED A COMPLETE REVIEW OF THE DEVICE HISTORY RECORDS (DHR) FOR DALE 240 LOT 21H2318 AND PERFORMED FUNCTIONAL TESTING ON SAMPLE 240 DEVICES FROM THIS LOT NUMBER. NO EVIDENCE OF ANY ISSUES WAS NOTED IN THE DOCUMENT REVIEW, AND TESTING FOUND THAT THE DEVICES MEET ALL INTERNAL TEST REQUIREMENTS FOR PEEL AND SHEAR TESTING. BASED ON OUR DOCUMENT REVIEW AND TESTING OF SAMPLES FROM THIS PRODUCTION LOT AND WITHOUT HAVING ACTUAL DEFECTIVE DEVICES TO REVIEW, DALE MEDICAL CANNOT CONFIRM A CAUSE FOR THE ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    "ADOLESCENT PATIENT WITH A TRACHEOSTOMY TUBE AND MECHANICAL VENTILATION. VELCRO PART OF THE TRACH HOLDER/STRAP WAS FOUND TO BE COMPLETELY DETACHED/BROKEN OFF FROM THE SOFT PART OF THE STRAP THAT ENCIRCLES THE NECK. THERE WAS NO ACTUAL PATIENT HARM. TRACH TUBE DID NOT BECOME DISLODGED BECAUSE THE VENT HOLDER (WHICH IS ALSO SECURED WITH VELCRO) WAS ATTACHED. TRACH HOLDER/STRAP WAS REPLACED UPON DISCOVERY OF BREAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089042 DALE TRACHEOSTOMY TUBE HOLDER TRACHEOSTOMY TUBE HOLDER CBH DALE MEDICAL PRODUCTS, INC. 240 21H2318 00817612020667

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male