BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPEEDICATH COMPACT EVE

    MDR report key: 7566462 · Received June 4, 2018

    Report

    Report Number
    9610694-2018-00002
    Event Type
    Injury
    Date Received
    June 4, 2018
    Report Date
    August 9, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    GBM
    PMA / PMN Number
    K150935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RISK ASSESSMENT: THE HARM IS COVERED IN THE PRODUCT RISK ASSESSMENT (VV-0051730) UNDER RISK NUMBERS 2031 AND 2032: 'CATHETER STAYS INSIDE URETHRA/BLADDER AS THE CATHETER DISLODGES FROM HANDLE/PRODUCT DURING USE'. FOR THIS CASE THE SEVERITY IS ASSESSED TO BE 3, MEANING: 'A TEMPORARY IMPAIRMENT OF BODY FUNCTION OR TEMPORARY DAMAGE TO BODY STRUCTURE OR DAMAGE TO PROPERTY/ENVIRONMENT. MAY REQUIRE MEDICAL INTERVENTION'. INVESTIGATIONS AND TESTS WERE PERFORMED TO ADDRESS THE FOLLOWING QUESTIONS: Q.1. IS IT POSSIBLE TO PULL FROM THE HANDLE? A.1. IT IS POSSIBLE, BUT WILL HAPPEN AT A FORCE OF APPROX. 35-45N, THE FORCE IS EQUIVALENT TO A PULL OF 3,5-4,5 KG, WHICH HAS BEEN EVALUATED TO SUFFICIENT COMPARED TO THE MINIMUM REQUIRED LOWER LIMIT OF 15N (1,5KG.) TEST IN STABILITY STUDY ALSO CONFIRM THAT STRENGTH IS SUFFICIENT Q.2. IS IT POSSIBLE TO PULL IF CATHETER MOULDING IS DEFECT? A.2. BASED ON INFORMATION GIVEN IT IS UNLIKELY THAT A MOULD DEFECT HAS BEEN PRESENT Q.3. WAS THE FORCE TO REMOVE CATHETER AFTER DRAINAGE LARGER THAN THE FORCE TO OPEN THE PRODUCT? A.3. YES, IT SEEMS TO BE THE CASE. BASED ON THE AVAILABLE INFORMATION IN THIS COMPLAINT AND THE EVALUATION OF THE SPEEDICATH COMPACT EVE CONSTRUCTION AND TEST DATA, IT IS NOT POSSIBLE TO GIVE AN EXPLANATION OF HOW THIS INCIDENT COULD OCCUR. IT SEEMS TO BE AN EXTREME CASE, WHERE IT HAS BEEN POSSIBLE TO DETACH THE CATHETER 1ST SHOT FROM THE HANDLE AND ALSO FROM THE 1ST SHOT OF THE CATHETER. EVEN IF DETACHED, IT SHOULD BE POSSIBLE TO REMOVE, AS THE CONNECTOR END OF CATHETER PART IS NOT INSERTED WHEN CATHETERIZING.

    Additional Manufacturer Narrative · 1

    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 OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, IT WAS REPORTED THAT THE CATHETER HANDLE WAS MISSING. THE PATIENT WAS ANAESTHETISED IN ORDER TO REMOVE THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407153 SPEEDICATH COMPACT EVE CATHETER, URETHRAL GBM COLOPLAST A/S 2811201006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other