BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSCH 2W 20ML 100% SILICONE STR H 18

    MDR report key: 14136307 · Received April 18, 2022

    Report

    Report Number
    8040412-2022-00106
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    April 7, 2022
    Report Date
    April 7, 2022
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    EZL
    UDI-DI
    04026704334964
    PMA / PMN Number
    K972184
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). THE BATCH CARD(S) FOR THE COMPLAINT LOT(S) WAS REVIEWED ALL SAMPLES PASSED QA INSPECTION. NO SAMPLE WAS RETURNED FOR INVESTIGATION; THEREFORE, NO PHYSICAL INVESTIGATION COULD BE CONDUCTED. IN THE ABSENCE OF ANY ACTUAL OR REPRESENTATIVE SAMPLE FOR INVESTIGATION, WE COULD NOT FURTHER INVESTIGATE TO IDENTIFY THE ACTUAL ROOT CAUSE OF THIS REPORTED FAILURE. THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    PATIENT REPORTING A 3RD FAILURE OF HIS RUSCH 100% 18FR 30CC FOLEY. HE SAID IT IS THE SAME LOT AS THE 2 YOU ARE ALREADY AWARE OF. THIS ONE IS KEY-MR. (B)(6). TOLD ME THE HISTORY AND THE 2 PREVIOUS BALLOONS BURST AFTER INSERTION AND HAD NOT BEEN PRE-TESTED. THE CLINICIAN THAT CAME TO INSERT THE LATEST CATHETER THAT FAILED PRE-TESTED THE BALLOON BEFORE INSERTION; IT BURST IN HIS HAND BEFORE 20ML WATER HAD BEEN INTRODUCED. THIS ELIMINATES THE POSSIBILITY OF SOMETHING WITHIN MR. (B)(6) BLADDER DAMAGING THE BALLOON (IE: STONES, OR DIFFUSION DUE TO OSMOSIS, ETC.). I JUST WANTED TO MAKE YOU AWARE SO THAT YOU COULD INCLUDE THE ADDITIONAL FAILURE AND NEW INFORMATION ON YOUR REPORT.

    Description of Event or Problem · 0

    PATIENT REPORTING A 3RD FAILURE OF HIS RUSCH 100% 18FR 30CC FOLEY. HE SAID IT IS THE SAME LOT AS THE 2 YOU ARE ALREADY AWARE OF. THIS ONE IS KEY-MR. W. TOLD ME THE HISTORY AND THE 2 PREVIOUS BALLOONS BURST AFTER INSERTION AND HAD NOT BEEN PRE-TESTED. THE CLINICIAN THAT CAME TO INSERT THE LATEST CATHETER THAT FAILED PRE-TESTED THE BALLOON BEFORE INSERTION; IT BURST IN HIS HAND BEFORE 20ML WATER HAD BEEN INTRODUCED. THIS ELIMINATES THE POSSIBILITY OF SOMETHING WITHIN MR. W. BLADDER DAMAGING THE BALLOON (IE: STONES, OR DIFFUSION DUE TO OSMOSIS, ETC.). I JUST WANTED TO MAKE YOU AWARE SO THAT YOU COULD INCLUDE THE ADDITIONAL FAILURE AND NEW INFORMATION ON YOUR REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627277 RUSCH 2W 20ML 100% SILICONE STR H 18 CATHETER, RETENTION TYPE, BALL EZL TELEFLEX MEDICAL SDN. BHD. IPN050171 KME21F1171 04026704334964

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown