BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX BLUE LINE SUCTIONAID

    MDR report key: 9215404 · Received October 21, 2019

    Report

    Report Number
    3012307300-2019-05612
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Date of Event
    October 10, 2019
    Report Date
    August 12, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: RETURNED DEVICE WAS RECEIVED IN USED PHYSICAL CONDITION. DURING THE EVALUATION OF THE RETURNED PRODUCT NO FAULTS WERE FOUND WITH A LEAK OR OTHERWISE. NO DISCREPANCIES WERE FOUND OVER THE COURSE OF 48 HOURS. THE FOLLOWING ARE RELEVANT DOCUMENTS WHICH WERE REVIEWED AND DEEMED ADEQUATE AND CORRECT WITH RESPECT TO TESTING AND INSPECTION ACTIVITIES: MP TRACHY BLU-TJ100 REV. 101 BLU/BLUS TRACHEOSTOMY TUBE ? CUFF INFLATION. QP TRACHY BLU-TJ REV. 106 TRACHY BLUE LINE ASSEMBLY AND PACKAGING. A REVIEW OF THE MANUFACTURING PROCESS FOR P/N 100/860/070 L/N 3994200 WAS CONDUCTED BY QUALITY ENGINEER ON 15/JUN/2020, IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT AS DESCRIBED IN ?DESCRIPTION OF NON-CONFORMANCE? SECTION. THE FOLLOWING OPERATIONS WERE REVIEWED, IN ORDER TO VERIFY THAT THE OPERATIONS WERE PROPERLY PERFORMED, ALSO TO ENSURE THAT THE OPERATIONS COMPLIED WITH GMP?S REQUIREMENTS AND SHM PROCEDURES: CUFF ASSEMBLY OPERATION WAS REVIEWED; NO DISCREPANCIES WERE FOUND. INFLATION LINE ASSEMBLY OPERATION WAS REVIEWED; NO DISCREPANCIES WERE FOUND. INFLATION TEST WAS AUDITED DURING THIRTY-TWO (32) UNITS P/N 100/860/070 L/N 3994200, IN ORDER TO VERIFY THAT THE INFLATION TEST WAS PROPERLY PERFORMED; THE INFLATION TEST WAS PERFORMED ACCORDING TO THE TEST METHOD STATED IN THE MANUFACTURING PROCEDURE; NO DEFLATED CUFFS WERE DETECTED DURING THE THIRTY-TWO (32) UNITS TESTED. PRODUCTION PERFORMS A 100% IN PROCESS INFLATION TEST TO THE CUFF AND VISUAL INSPECTED THAT CUFF HAS NO RAGGED EDGES. QUALITY TAKES A SAMPLE USING AN AQL 1.0 AND LEVEL INSPECTION GI, IN ORDER TO ENSURE THAT CUFF IS PROPERLY INFLATED. CUSTOMER REPORTED: ?PATIENT HAD TO BE RETURNED TO THE OPERATING THEATRE LAST 10/10/2019 FOR REINSERTION OF A NEW TRACHEOSTOMY TUBE BECAUSE APPARENTLY THE ONE PUT EARLIER WAS LEAKING.? NO ROOT CAUSE HAS TO BE DETERMINED SINCE THE COMPLAINT WAS NOT CONFIRMED SINCE NO ISSUES WERE FOUND WITH SHM PRODUCT. NO CORRECTIVE ACTIONS ARE REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED. AS PREVENTIVE ACTION, MANUFACTURING PERSONNEL WERE NOTIFIED BY THE SUPERVISOR AND QUALITY ENGINEER ON 13/JUL/2020 ABOUT FAILURE MODE REPORTED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: FOREIGN COUNTRY: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE ULTRA SUCTIONAID WAS IN USE WITH A PATIENT AT HOSPITAL. THE REPORTER STATED THE DEVICE WAS LEAKING AND A TUBE CHANGE OUT WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1008686 PORTEX BLUE LINE SUCTIONAID TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 2795873

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention