BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® HEYMAN FOLLOWER

    MDR report key: 7927865 · Received October 2, 2018

    Report

    Report Number
    1018233-2018-04549
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Report Date
    February 8, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FBW
    UDI-DI
    00801741075636
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURER RELATED. THE SAMPLES IN THE PHOTO WERE IN USED CONDITION. VISUAL EVALUATION NOTED THAT THE DEVICES WERE BLUNT. WE COULD NOT DETERMINED WHICH OF THE DEVICES WERE ASSOCIATED WITH EACH LOT USING THE PHOTOS OR ONCE THE PACKAGES WERE OPENED AND THE DEVICES WERE MIXED PER THE PHOTO. THE PHOTO SHOWED 8 DEVICES AND THE TAPERED FEATURE WAS NOT PRESENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿1. BARD® HEYMAN¿ FOLLOWERS ARE INTENDED TO BE USED WITH BARDEX® COUNCILL CATHETERS AND BARD® HEYMAN¿ FILIFORM CATHETERS. ALL INDIVIDUAL DEVICES ARE DISPOSABLE AND SOLD STERILE. 2. THE FILIFORM CATHETER COMES PACKAGED WITH A DISPOSABLE STYLET TO USE FOR INSERTION. INSERT THE BARD® HEYMAN¿ FILIFORM CATHETER WITH STYLET IN PLACE. THE FILIFORM CATHETER MAY BE PLACED BY INSERTING THROUGH A CYSTOSCOPE UNDER DIRECT VISION. DIRECT VIEW CATHETER PLACEMENT WILL DECREASE THE NUMBER OF DIFFICULT AND POSSIBLE FALSE PASSAGES. 3. THERE IS A 3 CENTIMETER ORIENTATION MARKING ON THE FILIFORM CATHETER AT 30 CENTIMETERS FROM THE DISTAL END TO ASSIST WITH PLACING THE FILIFORM CATHETER IN THE BLADDER. PLACEMENT OF THE FILIFORM CATHETER IN THE BLADDER CAN BE DETERMINED BY REMOVING THE STYLET AND OBSERVING URINE OR ASPIRATING URINE WITH A SYRINGE. IF ADDED CONFIRMATION IS NECESSARY, A RADIO GRAPH CAN BE TAKEN AFTER INJECTING RADIOPAQUE DYE INTO THE FILIFORM CATHETER. WHEN THE FILIFORM CATHETER HAS BEEN PROPERLY PLACED, THE STYLET SHOULD BE DISCARDED. 4. STARTING WITH THE SMALLER SIZES, SLIP THE BARD® HEYMAN¿ FOLLOWERS (STRAIGHT OR COUDE) OVER THE FILIFORM CATHETER. INCREASE THE FOLLOWER SIZE UNTIL THE DESIRED DILATION IS ACCOMPLISHED. 5. SLIP A BARDEX® COUNCILL CATHETER OVER THE FILIFORM CATHETER AND WHEN IT IS IN PLACE, INFLATE BALLOON. REMOVE THE FILIFORM CATHETER. IF, AT A LATER TIME, THE COUNCILL CATHETER IS TO BE REPLACED, INSERT A NEW FILIFORM CATHETER PRIOR TO REMOVING THE COUNCILL CATHETER. THE FILIFORM CATHETER WILL THEN GUIDE THE NEW COUNCILL CATHETER INTO PLACE. AFTER USE, THIS PRODUCT MAY BE POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. WARNING: BECAUSE THE FILIFORM CATHETER MAY ADVANCE WITH THE PASSAGE OF THE FOLLOWERS, A LENGTH OF THE FILIFORM CATHETER SHOULD ALWAYS APPEAR BEYOND THE PROXIMAL END OF THE FOLLOWER, OTHERWISE THE FILIFORM CATHETER MAY BE LEFT IN THE URETHRA WHEN THE FOLLOWER IS WITHDRAWN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEYMANN FOLLOWER HAD A BLUNT TIP INSTEAD OF A TAPERED TIP.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEYMANN FOLLOWER HAD A BLUNT TIP INSTEAD OF A TAPERED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767632 BARD® HEYMAN FOLLOWER HEYMANN FOLLOWER FBW C.R. BARD, INC. (COVINGTON) -1018233 021318 MCBV3103 00801741075636

    Patients

    Seq Age Sex Outcome Treatment
    1