BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FLOW PROSTATECTOMY CATHETER

    MDR report key: 17860700 · Received October 3, 2023

    Report

    Report Number
    9610711-2023-00206
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Report Date
    July 30, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN¿T FIND OTHER COMPLAINT ON THE LOT N° 9143103. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. WE INFORMED OUR HUNGARIAN SITE FOR THIS COMPLAINT AND WE SENT THE RECEIVED SAMPLE. THE HUNGARIAN'S INVESTIGATION CONCLUDED: "THE CONTAMINATION HAPPENED DURING THE PRODUCTION IN TATABANYA AS IT WAS INSIDE THE SECONDARY POUCH. WE COULDN'T WHAT KIND OF CONTAMINATION IS THIS AND WERE IT CAME FROM, BUT DURING OUR YEARLY RETRAINING WE SHOWED IT TO THE OPERATORS TO LOOK OUT FOR THIS KIND OF FAILURE. IN EVERY CASE DURING THE VISUALIZATION THE OPERATOR AT THE FINAL STEP SHOULD HAVE NOTICED THIS FAILURE AND SCRAPPED THE PRODUCT AND POUCH. THE OPERATORS HAVE BEEN RE TRAINED ."

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO CONTAMINATION. THERE WAS A SMALL YELLOW PARTICLE IN THE STERILE PACKAGING THAT WAS FOUND BEFORE USE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO CONTAMINATION. THERE WAS A SMALL YELLOW PARTICLE IN THE STERILE PACKAGING THAT WAS FOUND BEFORE USE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553485 X-FLOW PROSTATECTOMY CATHETER INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL EZL COLOPLAST A/S 9143103_AB63181002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown