BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE

    MDR report key: 13392937 · Received January 31, 2022

    Report

    Report Number
    1018233-2022-00251
    Event Type
    Malfunction
    Date Received
    January 31, 2022
    Date of Event
    January 10, 2022
    Report Date
    April 22, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741069727
    PMA / PMN Number
    K033477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 0

    UPON FURTHER REVIEW, IT HAS BEEN DETERMINED THAT THIS EVENT IS NOT REPORTABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REUSING THE MAGIC 3 GO HYDROPHILIC MALE INTERMITTENT CATHETER AND RUNNING UNDER WATER TO RE LUBRICATE THE CATHETER. IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED BLEEDING WHILE USING THE CATHETER. THE REPRESENTATIVE ADVISED THAT THE RUNNING UNDER WATER WOULD NOT RE LUBRICATE THE CATHETERS, AND THEY ONLY MEANT TO BE ONE TIME USE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS REUSING THE MAGIC 3 GO HYDROPHILIC MALE INTERMITTENT CATHETER AND RUNNING UNDER WATER TO RE LUBRICATE THE CATHETER. IT WAS ALSO STATED THAT THE PATIENT EXPERIENCED BLEEDING WHILE USING THE CATHETER. THE REPRESENTATIVE ADVISED THAT THE RUNNING UNDER WATER WOULD NOT RE LUBRICATE THE CATHETERS, AND THEY ONLY MEANT TO BE ONE TIME USE. IT WAS NOTED THAT THE PATIENT HAD BEEN USING THE PRODUCT FOR MORE THAN 90 DAYS. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW-UP VIA PHONE ON 07FEB2022, PATIENT STATED THAT NO MEDICAL ATTENTION REQUIRED FOR BLEEDING AND THEY RECEIVED A DIFFERENT CATHETER AND NO LONGER HAD ANY CATHETER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927000 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE MAGIC3 INTERMITTENT CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 53516G NGBP0262 00801741069727
    2277653 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE MAGIC3 INTERMITTENT CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 53516G NGBP0262 00801741069727

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other