BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLYSIL CATHETER

    MDR report key: 16791751 · Received April 21, 2023

    Report

    Report Number
    9610711-2023-00065
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Report Date
    May 18, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040127490
    PMA / PMN Number
    K013174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT AND CAPA. DEVICES MET SPECIFICATION PRIOR TO RELEASE AND NO TRENDS WERE NOTED. 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

    THIS PRODUCT REFERENCE AA61161002 LOT NUMBER 8459933 HAS BEEN MANUFACTURED FOR 1940 PIECES WITH INTERMEDIATE PRODUCTS AA611680 LOT 8231611 MADE BY OUR TUNISIAN SUBCONTRACTOR CHECKING THE QUALITY DATABASE REVEALED ONE CHANGE CONTROL CC (B)(4) "PACKAGING - ADDITION OF LONGITUNAL PRECUTS" OPENED ON SEPTEMBER 2013 AND CLOSED ON JANUARY 2014 WE RECEIVED THE SAMPLE WITH PACKAGING AND WE CAN SEE THE OPENING OF THE PACKAGING WITH THE DISTAL TIP TORN IN ADDITION, WE HAVE ALREADY HAD SIMILAR COMPLAINTS RECEIVED ON THE SAME ISSUE, ROOT CAUSE IDENTIFIED AT THAT TIME WAS THAT CUSTOMERS USED THE TRANSVERSAL PRE-CUTS AVAILABLE ON THE INNER POUCH AND PINCHED THE DISTAL END OF THE CATHETERS DURING OPENING OF THE PACKAGING. CONSEQUENTLY, THE DISTAL END OF THE CATHETERS BROKE BEFORE USE OR ARE DAMAGED. SINCE IMPLANTATION OF CHANGE CONTROL (B)(4), IT IS STRONGLY RECOMMENDED TO USE LONGITUDINAL PRECUTS. TRANSVERSAL PRECUT IS NOT RECOMMENDED AND SHOULD BE USED WITH GREAT CAUTION.

    Description of Event or Problem · 0

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS NOT ABLE TO BE USED DUE TO A BREAK. THE PACKAGING WAS OPENED AND THE TIP THAT PENETRATES THE URETHRA WAS TORN OFF WITHOUT PUTTING SIGNIFICANT TRACTION ON THE TIP. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965868 FOLYSIL CATHETER CATHETER, RETENTION TYPE, BALLOON EZL COLOPLAST A/S AA61161002 8459933 03600040127490

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown