BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 3W STD SLC CH16

    MDR report key: 3140022 · Received May 29, 2013

    Report

    Report Number
    9611710-2013-00255
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    KOD
    PMA / PMN Number
    K944007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED TO THE FDA ON (B)(4) 2013. THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "DIFFICULT DEFLATION IN USE WAS NOTED, SO THE PATIENT SUFFERED FROM HEMATURIA. THE COMPLAINT SAMPLE WAS SEVERELY CONTAMINATED, SO IT WAS DISCARDED". THIS CASE IS DEEMED SERIOUS AS IT WAS REPORTED THAT THE BALLOON OF THE URINARY CATHETER HAD BEEN DIFFICULT TO DEFLATE AND THE PATIENT SUFFERED SOME BLEEDING DURING THE PROCESS OF REMOVING THE DEVICE. NO OTHER DETAILS ARE KNOWN AT THIS TIME, HENCE WE HAVE REQUESTED FOR FURTHER PATIENT/ EVENT DETAILS. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE CATHETER AND THIS EVENT IS DEEMED POSSIBLE. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION AND THE FOLLOWING WAS RECEIVED "THIS CASE WAS FORWARDED FROM THE B)(6) HOSPITAL. THE COMPLAINT SAMPLE WAS DISCARDED AND THE END USER DID NOT WANT TO REVEAL MORE INFORMATION EXCEPT THAT THE PATIENT'S CONDITION WAS STABLE". ACTUAL ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AS THE COMPLAINT SAMPLE IS NOT EXPECTED TO BE AVAILABLE FOR EVALUATION. BASED ON THE HISTORY REVIEW DID NOT ANY SIGNIFICANT ABNORMALITIES. HOWEVER, IN MOST CASES OF SUCH COMPLAINT ON NON DEFLATION DURING USE COULD PROBABLY BEEN DUE TO EITHER OF THE FOLLOWING FACTORS:- MECHANICAL OBSTRUCTION OF THE INFLATION LUMEN DUE TO CRUSHING, CLAMPING OR PROLONGED KINKING OF THE PORT LEADING TO THE BALLOON. CRYSTALLIZATION OF INAPPROPRIATE FLUIDS FILING THE BALLOON SUCH AS NORMAL SALINE OTHER ELECTROLYTE SOLUTION. DEFECTIVE CATHETER VALVE. EXTRINSIC COMPRESSION FROM IODINE RADIUM SEEDS IMPLANTS. OBSTRUCTION OF THE INFLATION CHANNEL BY DEBRIS. MANUFACTURING DEFECT SUCH AS BLOCKED AT THE "Y" JUNCTION DERIVED FROM THE THREADING PROCESS, SMALL INFLATION HOLE OR COLLAPSED INFLATION LUMEN CAUSED BY UNEVEN WALL THICKNESS. DEFLATION TECHNIQUE LIKE: IMPROPER SYRINGE INSERTION TECHNIQUE. SYRINGE BARREL NOT ADEQUATELY/ SECURELY INSERTED INTO THE VALVE ORIFICE, THUS, RESTRICTS/ PREVENT DEFLATION. "FORCE" INSTEAD OF "NATURAL DRAINAGE". SYRINGE PLUNGER IS USER TO ASPIRATE/ WITHDRAWAL THE WATER FROM THE BALLOON WHICH CAUSES THE INFLATION FUNNEL TO COLLAPSE, THUS, RESTRICTS/ PREVENT DEFLATION. UNDER NORMAL CIRCUMSTANCES, THE WATER IS SUPPOSED TO DRAIN FREELY VIA AN EMPTY SYRINGE BARREL AND NOT WITH THE PLUNGER FITTED. ONLY THE RESIDUAL FLUID REMOVED VIA ASPIRATION IF IT CANNOT BE DRAINED COMPLETELY VIA THE SYRINGE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233796 FOLEY CATHETER, 3W STD SLC CH16 UROLOGICAL CATHETER AND ACCESSORIES KOD UNOMEDICAL SDN BHD MM55181630 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1