BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCATH 2 WAY HYDROGEL COATED FOLEY CATHETER, 30CC, 18 FR.

    MDR report key: 3022515 · Received March 20, 2013

    Report

    Report Number
    1018233-2013-00853
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BARD SDN. BHD.
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE LOT NUMBER IS UNK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES UNDER CAUTION: "THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ON (B)(6) 2013 MR (B)(6) INSERTED A BARD BIOCATH 18FG INTO ONE OF HIS PTS FOLLOWING A FLEXIBLE CYSTOSCOPY AND COONS DILATATION TO HIS BLADDER NECK. THE PT PHONED LATE ON (B)(6) TO SAY HE HAD PUS COMING DOWN THE SIDES OF THE CATHETER AND IT FELT EXTREMELY IRRITATED, WITH PAIN RADIATING DOWN HIS URETHRA. THE PT (BEING A DOCTOR), TOOK A SWAB TO RULE OUT AN INFECTION. THE RESULT WAS NEGATIVE. IT WAS ARRANGED FOR HIM TO COME IN THE FOLLOWING MORNING FOR A TRIAL REMOVAL. THIS PROCEDURE WENT WELL AND HE VOIDED ALMOST IMMEDIATELY FOLLOWING THE REMOVAL OF THE CATHETER, THURSDAY MORNING. THE PT SAID HE FELT MUCH BETTER ONCE THE CATHETER WAS OUT. HOWEVER HE WAS GIVEN SOME LIGNOCAINE (10GM SYRINGE), TO PUT ON THE TIP OF HIS URETHRA TO HELP EASE THE PAIN. UPON FOLLOWING UP, THE PT REPORTED FEELING BETTER. HE SAID IT TOOK A COUPLE OF DAYS FOR THE PAIN TO EASE COMPLETELY BUT THERE WAS DRAMATIC IMPROVEMENT INITIALLY ON REMOVAL OF THE CATHETER. AS FAR AS THE REPORTER IS AWARE, NONE OF THE OTHER DOCTORS AT THE FACILITY HAVE HAD ISSUES WITH THAT PARTICULAR CATHETER. THE PTS CONTINUED TO HAVE SMALL AMOUNTS OF PUS UNTIL (B)(6). IRRITATION OF THE URETHRA WAS MUCH IMPROVED BY (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115764 BIOCATH 2 WAY HYDROGEL COATED FOLEY CATHETER, 30CC, 18 FR. EZC BARD SDN. BHD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention