BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC3 TOUCHLESS WITH PVI ACCESSORIES

    MDR report key: 5956249 · Received September 16, 2016

    Report

    Report Number
    1018233-2016-01237
    Event Type
    Injury
    Date Received
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    MJC
    PMA / PMN Number
    K033477
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "PLACE YOUR NONDOMINANT HAND ON THE SURE-GRIP¿ SLEEVE TO STABILIZE CATHETER IN URETHRA. WITH YOUR DOMINANT HAND, GRASP CATHETER THROUGH BAG APPROXIMATELY 1" BELOW THE SURE-GRIP¿ SLEEVE AND PUSH CATHETER INTO URETHRA. THE CATHETER SHOULD BE INTRODUCED BY SHORT, REPETITIVE PUSHING MOTIONS. REPEAT MOTIONS UNTIL CATHETER REACHES BLADDER AND URINE STARTS TO FLOW. ALLOW URINE TO FLOW FREELY, MAKING CERTAIN THE SURE-GRIP¿ SLEEVE IS ELEVATED AT LEAST 4" ABOVE LOWER PORTION OF THE BAG. ALLOW FLOW UNTIL BLADDER IS EMPTY OR UNTIL BAG IS FILLED. PRECAUTION: IT IS RECOMMENDED THAT THE COLLECTION BAG BE HELD. THE CATHETER COULD POSSIBLY SEPARATE FROM THE COLLECTION BAG WHEN URINE INCREASES WEIGHT OF THE BAG." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLEY CATHETER DISCONNECTED FROM THE SAMPLE PORT CONNECTOR. IT WAS ALLEGED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTIONS AS A RESULT OF THE DISCONNECTION. THE PHYSICIAN ALLEGEDLY PRESCRIBED ANTIBIOTICS FOR TREATMENT. IT WAS LATER REPORTED THAT THE MAGIC 3 TOUCHLESS CATHETER WAS DISCONNECTING FROM THE GREEN INSERTION SLEEVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLEY CATHETER DISCONNECTED FROM THE SAMPLE PORT CONNECTOR. IT WAS ALLEGED THAT THE PATIENT EXPERIENCED URINARY TRACT INFECTIONS AS A RESULT OF THE DISCONNECTION. THE PHYSICIAN PRESCRIBED ANTIBIOTICS FOR TREATMENT. IT WAS LATER REPORTED THAT THE MAGIC 3 TOUCHLESS CATHETER WAS DISCONNECTING FROM THE GREEN INSERTION SLEEVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607539 MAGIC3 TOUCHLESS WITH PVI ACCESSORIES M3 TOUCHLESS CATHETER MJC PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 NGAQ4446

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention