BEUDAMED
    FDA Adverse Event Other Summary report: N

    URINARY CATHETER-NELATON UST. 12/040CM/78 2C

    MDR report key: 3122639 · Received May 16, 2013

    Report

    Report Number
    3005778470-2013-00024
    Event Type
    Other
    Date Received
    May 16, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 16, 2013
    Manufacturer
    CONVATEC
    Product Code
    KOD
    PMA / PMN Number
    K896729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT 'BLEEDING PER URETHRA AFTER CATHETERIZATION' IS DEEMED SERIOUS, AS IT MAY SOMETIMES REQUIRE A SURGICAL OR MEDICAL INTERVENTION TO CONTROL THE BLEEDING AND TO PRECLUDE A MORE SERIOUS CONSEQUENCE FOR THE PT. IN THIS CASE, THE BLEEDING STOPPED SPONTANEOUSLY AND THERE WAS NO REPORT OF THE PT SUFFERING A PERMANENT DAMAGE TO BODILY STRUCTURE OR FUNCTION. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE CATHETER AND THE EVENT IS DEEMED POSSIBLE BECAUSE PRODUCT USE IS TEMPORALLY ASSOCIATED WITH THE PART OF THE BODY WHERE THE PROBLEM OCCURRED. ONE HUNDRED FIFTY EIGHT UNUSED SAMPLE IN CLOSED PEEL PACKS WERE RECEIVED AND TESTED. THE SAMPLES WERE INSPECTED. THE SAMPLES MET SPECIFICATION. NO SHARP EDGES HAVE BEEN OBSERVED. HISTORY BATCH RECORDS HAVE BEEN REVIEWED AND NO NONCONFORMITY WAS RECORDED DURING THE MFG PROCESS. ALL RELEVANT TESTS REQUIRED DURING MFG PROCESS AND FINAL PRODUCT RELEASES WERE PERFORMED AND MET REQUIREMENTS. NO OTHER COMPLAINT WAS RECEIVED FOR THE SAME PRODUCT REFERENCE CODE WITHIN LAST 2 YEARS. THE PUNCHED HOLES AND THE TIP ROUNDING ARE CHECKED BY A TECHNICIAN AFTER MACHINE ALIGNMENT. DURING PRODUCTION WITHIN IN PROCESS INSPECTION ALL CATHETERS ARE CHECKED BY OPERATORS AS WELL. NO SHARP EDGES, FINS AND THE SHARP BURRS ARE ALLOWED. BASED ON ABOVE THE ROOT CAUSE OF THE DEFECT CANNOT BE DETERMINED. THE FAILURE IS INCLUDED IN RELEVANT RISK MANAGEMENT FILE AND ASSOCIATED HAZARD IS EVALUATED THERE. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED FROM DISTRIBUTOR AS FOLLOWS: "THIS PT USED TO USE THESE NELATONS AND HAD NEVER ANY PROBLEM IN THE PAST, ONLY HE HAD THE PROBLEM WITH THIS LOT 453929, HE OBSERVED THE BLEEDING AFTER CATHETERIZATION. THE BLEEDING WAS STOPPED WHEN HE USED DIFFERENT LOT NUMBER OF THIS NELATON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216604 URINARY CATHETER-NELATON UST. 12/040CM/78 2C CATHETER, UROLOGICAL KOD CONVATEC 01008184 453929

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other