BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ INJECTOR LUER LOCK N35

    MDR report key: 17122626 · Received June 13, 2023

    Report

    Report Number
    3003152976-2023-00228
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 31, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905150036
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, IT CAN BE OBSERVED THAT THE MEMBRANE OF THE INJECTOR HAS BEEN PENETRATED SINCE IT HAS BEEN STAINED WITH THE COLOR OF THE RED CYTOSTATIC LIQUID. A FAIRLY LARGE HOLE IN THE MEMBRANE CAN BE OBSERVED, WHICH GIVES AN INDICATION THAT THE MEMBRANE HAS BEEN PUNCTURED MORE THAN 10 TIMES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2110013, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE INJECTOR ALONG WITH A SAMPLE PROTECTOR TEN TIMES, ALL RESULTS WERE FOUND TO BE ACCEPTABLE WITH NO LEAKS IDENTIFIED. DURING MANUFACTURING, LEAKAGE TESTING IS PERFORMED, PENETRATING THE INJECTOR TEN TIMES TO VERIFY IF ANY LEAKS OCCUR. TESTING WAS REVIEWED FOR INJECTOR LOT 2110013 ALONG WITH THE PROTECTOR IT WAS MATED TO, ALL RESULTS WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION POSSIBLE ROOT CAUSE IS ASSOCIATED WITH EXCESSIVE PERFORATION OF THE MEMBRANE. THE PERFORMANCE OF THE SEALING MEMBRANE IS REDUCED AFTER MULTIPLE PUNCTURES AND PROLONGED ACTIVATION TIME. IT IS IMPORTANT TO FOLLOW THE INSTRUCTIONS FOR USE WHEN USING PHASEAL DEVICES TO ENSURE PROPER PRODUCT PERFORMANCE. AS INDICATED IN THE PACKAGE INSERT, THE INJECTOR AND CONNECTOR (LUER-LOCK) SHOULD NOT BE USED REPEATEDLY OR IN A MANNER THAT WILL DAMAGE THE MEMBRANE. AFTER REPEATED OR PROLONGED USE OF THE INJECTOR AND CONNECTOR (LUER-LOCK), THE PERFORMANCE OF THE MEMBRANE MAY GRADUALLY DEGRADE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ INJECTOR LUER LOCK N35 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF CHEMOTHERAPY DRUG HAPPENED DURING DRUG RECONSTITUTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ INJECTOR LUER LOCK N35 LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE OF CHEMOTHERAPY DRUG HAPPENED DURING DRUG RECONSTITUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409683 BD PHASEAL¿ INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515003 2110013 00382905150036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown