BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Cure Catheter® Closed System

    MDR report key: 15275773 · Received August 23, 2022

    Report

    Report Number
    1049092-2022-00320
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Report Date
    August 16, 2022
    Manufacturer
    CONVATEC INC
    Product Code
    FCM
    UDI-DI
    00815947020666
    PMA / PMN Number
    K080881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE 2 OF 3. COMMON DEVICE NAME: CATHETER, UROLOGICAL. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 0

    END USER'S GRANDMOTHER REPORTS "SHE CATHS HIM 4 X A DAY AS HE WAS IN AN AUTOMOBILE ACCIDENT RESULTING HIM QUADRIPLEGIA AND NO FEELING OF HIS BLADDER AND SHE CATHS HIM 4 X A DAY FOR RETENTION. SHE REPORTS FOR THE CS12, THE DEFECT SHE REPORTS IS THAT THE CATHETER TIP IS NOT IN THE BLUE GUIDE PART, IT IS FLOATING IN THE BAG MAKING IT UNUSABLE - SHE REPORTS UNKNOWN QTY OF DEFECTED CATHETERS, "MAYBE 1 OR 2 A MONTH FOR ABOUT THE LAST 6 MONTHS" FROM UNKNOWN MU/S OF UNKNOWN LOTS. CURRENT MU BOX SHE JUST FOUND QTY 2 AFFECTED CATHETERS IS OF LOT # 220222-2. SHE STATES SHE DISCARDS THEM AS THEY ARE UNUSABLE. SHE SAID SHE HAS NOTICED THIS START TO OCCUR ONLY FOR ABOUT THE LAST 6 MONTHS OR SO WITH MAYBE 1 OR 2 A MONTH SHE FINDS LIKE THIS OF THESE CATHETERS. SHE SAID SHE CANNOT USE AS THEY ARE UNUSABLE AS NO WAY FOR HER TO GET IN HIS PENIS. SHE SAID SHE CANNOT MAKE THE CATHETER TIP FLOATING IN BAG GO IN THE BLUE GUIDE WITHOUT OPENING THE BAG AND SHE DIDN'T THINK IT WOULD BE GOOD FOR HER TO OPEN THE BAG AND CONTAMINATE IT BECAUSE SHE KNOWS IT IS STERILE." SHE WAS ADVISED TO CONTINUE TO "NOT USE AND SHE DID THE CORRECT THING BY NOT USING CATHETERS SHE FINDS LIKE THIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2855000 Cure Catheter® Closed System Tray, catheterization, sterile urethral, with or without catheter (kit) FCM CONVATEC INC 510800 220222-2 00815947020666

    Patients

    Seq Age Sex Outcome Treatment
    1 Male