BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE CATHETER

    MDR report key: 4427221 · Received January 13, 2015

    Report

    Report Number
    3006430057-2015-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    May 20, 2014
    Report Date
    January 7, 2015
    Manufacturer
    INTEGRAL MEDICAL PRODUCTS CO. LTD.
    Product Code
    EZD
    PMA / PMN Number
    K072539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS PRODUCED AT OUR FACILITY AS A CONTRACT MFR, AND WE FIRST UNDERSTOOD OUT RESPONSIBILITY FOR REPORTING UNDER 21 CFR 803 ON 12/18/2014. THIS REPORT IS MADE WITHIN 20-DAYS OF OUR NEW KNOWLEDGE. THE DEVICE WAS NOT RETURNED TO INTEGRAL MEDICAL PRODUCTS CO, LTD FOR EVAL, SW WE DID NO TESTING ON THE RETURNED DEVICE (B)(4) AND WE HAVE NO RESULTS TO REPORT ON ANY TESTING (B)(4). AS A RESULT OF THE INCIDENT, A POTENTIAL INFECTION OF UTI EXISTED CODE (B)(4), AND IT IS BELIEVED THIS IS DUE TO INJURY CAUSED BY FOREIGN MATERIAL PRESENT IN THE DEVICE (B)(4). AT THE REQUEST OF THE SPECIFICATION DEVELOPER, WE EVALUATED THE PRODUCTION PROCESS AND CANNOT CONFIRM IDENTIFY OR SOURCE OF METAL CLIPS AS DESCRIBED BY BOTH THE USER AND THE SPECIFICATION DEVELOPER. INFO FROM THE SPECIFICATION DEVELOPER TELLS US THAT THE PRIMARY PACKAGING SHOWS NO EVIDENCE OF DAMAGE DUE TO THE PRESENCE OF THE METAL CLIP AND THERE ARE NO WITNESS MARKS. THE CATHETER SHOWS NO EVIDENCE THAT ANY FOREIGN BODY, INCLUDING A METAL CLIP WAS EVER EMBEDDED OR ADHERING TO IT. WE DETECTED NO FAILURE (B)(4); THE CATHETER, INCLUDING PACKAGING, APPEAR TO MEET SPECS (B)(4).

    Description of Event or Problem · 1

    PT REPORTED TO THE SPECIFICATION DEVELOPER ON (B)(6) 2014 THAT HE HAD BEEN SCRATCHED BY A PIECE OF METAL HE FOUND NEAR THE EYELETS OF A CATHETER AFTER WITHDRAWAL. HE HAD SOME BLEEDING. HE RETURNED EVERYTHING TO THE SPECIFICATION DEVELOPER, AND NOT TO INTEGRAL MEDICAL PRODUCTS CO, LTD, WHICH INCLUDED THE METAL, WHICH WAS A CLIP MEASURING 12MM X 2MM. INITIALLY THE PT THOUGHT HE NEEDED NO MEDICAL ATTENTION, BECAUSE THE NEXT TIME HE CATHETERIZED, ALL WENT FINE WITHOUT ANY BLEEDING. IN THE ENSUING WEEK, HE HAD SOME BLOOD IN HIS URINE, SO HE CONSULTED HIS DOCTOR. (REPORTED ON (B)(6) 2014). HE SEEMED FINE. OVER THE NEXT WEEK HIS URINE DEVELOPED A STRONG SMELL AND HAD SOME BLOOD SO HE VISITED HIS UROLOGIST. ON (B)(6) 2014, HE REPORTED BEING PRESCRIBED AN ANTIBIOTICS FOR A POSSIBLE INFECTION. HE DOES NOT KNOW WHERE THE METAL PIECE CAME FROM. HE FIRST SAW IT ON THE CATHETER UPON WITHDRAWAL AFTER FEELING CONSIDERABLE PAIN. HE THOUGHT PART OF THE CLIP MAY HAVE BEEN INSIDE AN EYELET. HE IS UNCERTAIN AS TO WHETHER THE CLIP CAME FROM THE TUBE OF LUBRICANT. HE DID NOT SEE THE CLIP ON THE CATHETER OR PACKAGING WHEN HE OPENED IT FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27822 CURE CATHETER UROLOGICAL CATHETER EZD INTEGRAL MEDICAL PRODUCTS CO. LTD. M16 130712-2

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR HR PHARMECEUTICALS LUBRICATING JELLY, 4OZ TUBE