BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAHURKAR

    MDR report key: 22066543 · Received May 21, 2025

    Report

    Report Number
    1282497-2025-00342
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    April 29, 2025
    Report Date
    July 31, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    MPB
    UDI-DI
    10884521006539
    PMA / PMN Number
    K192302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10-CONCOMITANT PRODUCT: 8888135241 13.5FR 24CM MAHKA Q+ SE KIT- LOT #: 2327000135 8888135241 13.5FR 24CM MAHKA Q+ SE KIT- LOT #: 2327000135 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THE PUNCTURE, THE GUIDEWIRE GOT STUCK IN THE NEEDLE AND CANNOT BE MOVED. THERE ARE THREE CONSECUTIVE CATHETER CHANGES. THE SAME ISSUE WAS OBSERVED DURING ALL THREE CONSECUTIVE CATHETER CHANGES. ALL THREE CATHETER CHANGES OCCURRED DURING THE SAME EVENT. ALL THREE CATHETERS WERE REPORTED TO HAVE BEEN IN THE SAME PATIENT. THERE WAS NOTHING UNUSUAL TO OBSERVE ON THE DEVICE PRIOR TO USE. THERE WAS NO EXCESSIVE FORCE USED ON THE DEVICE. THERE WERE NO OTHER PRODUCTS BEING UTILIZED WITH THE DEVICE. FLUSHING WAS DONE, AND THE RESULT WAS NORMAL. THE CATHETER WAS NOT REPAIRED. THERE WAS NO LEAK. THERE WAS NO CLEANING AGENT USED ON THE DEVICE. TEGO WAS NOT UTILIZED. THERE WAS NO LUER ADAPTER ISSUE. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. BESIDES THE REPORTED ISSUE, THERE WERE NO OTHER VISIBLE DEFECTS/DAMAGES FOUND ON THE PRODUCT AT THE TIME OF THE EVENT. THE GUIDEWIRE PROVIDED WITH THE KIT WAS BEING USED. THE GUIDEWIRE WAS INTACT UPON REMOVAL. THE GUIDEWIRE WAS STUCK IN THE NEEDLE AND WAS REMOVED FROM THE PATIENT TOGETHER WITH THE NEEDLE. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH THE NEW CATHETER, AND THE SURGERY WAS COMPLETED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING THE PUNCTURE, THE GUIDEWIRE BECAME STUCK IN THE NEEDLE AND COULD NOT BE MOVED. THIS ISSUE OCCURRED DURING THREE CONSECUTIVE CATHETER CHANGES, ALL OF WHICH TOOK PLACE DURING THE SAME PROCEDURE AND INVOLVED THE SAME PATIENT. THERE WERE NO ABNORMALITIES OBSERVED ON THE DEVICES PRIOR TO USE. NO EXCESSIVE FORCE WAS APPLIED, AND NO OTHER PRODUCTS WERE UTILIZED WITH THE DEVICE. FLUSHING WAS PERFORMED AND WITH A NORMAL RESULTS. THE CATHETERS WERE NOT REPAIRED, AND NO LEAKS WERE NOTED. NO CLEANINGAGENTS WERE USED, TEGO WERE NOT UTILIZED, AND THERE WERE NO ISSUES WITH THE LUER ADAPTER. THE INSERTION SITE WAS NOT TREATED PRIOR TO PRODUCT PLACEMENT. ASIDE FROM THE REPORTED ISSUE, NO VISIBLE DEFECTS OR DAMAGE WERE OBSERVED ON THE PRODUCTS AT THE TIME OF THE EVENT. THE GUIDEWIRE REMAINED INTACT UPON REMOVAL. THE GUIDEWIRE, WHICH WAS STUCK IN THE NEEDLE, WAS REMOVED FROM THE PATIENT ALONG WITH THE NEEDLE. AS A REMEDIAL ACTION, THE REPORTED PRODUCT WAS REPLACED WITH A NEW CATHETER, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO INTERVENTION/TREATMENT REQUIRED AS A RESULT OF THE EVENT. THERE WAS NO BLOOD LOSS, AND BLOOD TRANSFUSION WAS NOT REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819811 MAHURKAR CATHETER, HEMODIALYSIS, NON-IMPLANTED MPB COVIDIEN LLC 8888135241 2327000135 10884521006539

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Unknown SEE H11.