BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURE CATHETER

    MDR report key: 3928971 · Received June 18, 2014

    Report

    Report Number
    3005471919-2014-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 18, 2014
    Manufacturer
    CURE MEDICAL LLC.
    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

    MANUFACTURER INVESTIGATED PRODUCTION PROCESS. MANUFACTURER CANNOT CONFIRM IDENTIFY OR SOURCE OF METAL CLIP RETURNED WITH DEVICE. PRIMARY PACKAGING SHOWS NO EVIDENCE OF DAMAGE OR WITNESS MARK FROM METAL CLIP. CATHETER SHOWS NO EVIDENCE THAT ANY FOREIGN BODY WAS EVER EMBEDDED IN OR ADHERED TO IT. METAL CLIP APPEARS TOO LARGE TO PASS THROUGH THE URETHRA ON THE EXTERIOR SURFACE OF THE CATHETER. BASED ON PT'S ORIGINAL REPORT OF EVENT, MANUFACTURER IS REPORTING THE EVENT AS AN UNCONFIRMED PRODUCT PROBLEM, MALFUNCTION. PURPOSE: REPORT FINDINGS OF THE EVALUATION OF PRODUCT RETURNED ON CURE COMPLAINT (B)(4). BACKGROUND: A COMPLAINT WAS REPORTED ON (B)(6) 2014 FOR AN M16 CURE CATHETER HAVING A METAL CLIP IN THE PACKAGE OR STUCK TO THE CATHETER. IN PREPARATION, PT HELD THE CATHETER IN ONE HAND AND APPLIED (B)(4) LUBRICATING JELLY FROM A TUBE USING THE OTHER HAND. PT DID NOT NOTICE THE CLIP PRIOR TO USE, BUT REPORTED HEMATURIA AND SEVERE DISCOMFORT ON WITHDRAWING THE CATHETER. PT BELIEVES METAL CLIP WAS ADHERED TO EXTERIOR SURFACE OF CATHETER AND INTRODUCED INTO AND WITHDRAWN FROM URETHRA. PT STATES THE CLIP WAS NOT IN THE EYELET, BUT NEAR THE EYELET. METHOD: ON (B)(6) 2014, USER RETURNED 1 USED M16 UNIT WITH OPEN PRIMARY PACKAGE LOT: 130712-2. EXPIRY: 2018-06, AND A 12 MM X 2 MM METAL CLIP. THE RETURNED DEVICE, PACKAGING AND METAL CLIP WERE INSPECTED USING 10X MAGNIFICATION FOR DEFECTS OR SIGNS THAT THE METAL CLIP MAY HAVE BEEN ADHERED TO OR IMBEDDED IN THE CATHETER. PHOTOS OF THE METAL CLIP WERE SENT TO THE CATHETER MANUFACTURER/PACKAGER (B)(4) AND THE LUBE JELLY MANUFACTURER, (B)(4) FOR INVESTIGATION. THE COMPLAINT FILES WERE REVIEWED FOR SIMILAR COMPLAINTS OR OTHER COMPLAINTS FROM THIS LOT. RESULTS: THE CATHETER ITSELF APPEARS TO CONFORM TO SPECIFICATION. THE METAL CLIP APPEARS TO BE A NONMAGNETIC GRADE OF STAINLESS STEEL. THE CLIP HAS WELL-WORN CORNERS AND DOES NOT APPEAR BROKEN-OFF OR PARTICULARLY SHARP. THE CLIP HAS NO EVIDENCE OF CORROSION. THERE IS NO VISUAL EVIDENCE THAT THE METAL CLIP WAS FIRMLY ADHERED TO OR EMBEDDED IN THE CATHETER. THERE IS NO WITNESS MARK OR PUNCTURE ON THE PACKAGING THAT WOULD INDICATE THE CLIP WAS INSIDE THE PACKAGE. (B)(4) REPORTED THAT THE METAL CLIP IS NOT LIKE ANYTHING USED AT THEIR FACILITY. (B)(4) HAS NOT YET COMPLETED THEIR INVESTIGATION REGARDING POSSIBLE IDENTIFICATION OF METAL CLIP. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED IN THE PAST. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THE LOT 130712-2. FINDINGS: WHILE THE METAL CLIP WAS SUBMITTED WITH THE DEVICE, THE COMPLAINT THAT THE METAL CLIP WAS ADHERED TO THE CATHETER DURING WITHDRAWAL IS UNCONFIRMED. THE SOURCE OF THE CLIP REMAINS UNDETERMINED.

    Description of Event or Problem · 1

    PT REPORTED 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 THE METAL PIECE WHICH WAS A CLIP, SIZE 12 MM X 2 MM, ALONG WITH THE CATHETER AND PRIMARY PACKAGING TO THE MANUFACTURER. AT FIRST, THE PT THOUGHT HE NEEDED NO MEDICAL ATTENTION, BECAUSE THE NEXT CATHETERIZATION WENT FINE WITH NO BLOOD. IN THE ENSUING WEEK, HE HAD SOME BLOOD IN HIS URINE AGAIN, SO HE CONSULTED HIS DOCTOR. (REPORTED ON (B)(6)) 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 ANTIBIOTIC 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
    359235 CURE CATHETER UROLOGICAL CATHETER EZD CURE MEDICAL LLC. M16 130712-02

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR (B)(4) LUBRICATING JELLY, 4OZ TUBE