BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 8758127 · Received July 3, 2019

    Report

    Report Number
    1018233-2019-03603
    Event Type
    Malfunction
    Date Received
    July 3, 2019
    Date of Event
    May 22, 2019
    Report Date
    July 24, 2019
    Manufacturer
    PUREWICK CORPORATION ¿ 3012224959
    Product Code
    NZU
    UDI-DI
    00801741143083
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO ¿INADEQUATE LABEL CONTENTS¿ WHERE THE LABEL DOES NOT SPECIFICALLY MENTIONS THE USE OF LATEX IN THE DRY NATURAL RUBBER PROCESS. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿WARNINGS: DO NOT USE THE PUREWICKTM FEMALE EXTERNAL CATHETER WITH BEDPAN OR ANY MATERIAL THAT DOES NOT ALLOW FOR SUFFICIENT AIRFLOW. TO AVOID POTENTIAL SKIN INJURY, NEVER PUSH OR PULL THE PUREWICKTM FEMALE EXTERNAL CATHETER AGAINST THE SKIN DURING PLACEMENT OR REMOVAL. NEVER INSERT THE PUREWICKTM FEMALE EXTERNAL CATHETER INTO VAGINA, ANAL CANAL, OR OTHER BODY CAVITIES. DISCONTINUE USE IF AN ALLERGIC REACTION OCCURS. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. PRECAUTIONS: NOT RECOMMENDED FOR PATIENTS WHO ARE: AGITATED, COMBATIVE, OR UNCOOPERATIVE AND MIGHT REMOVE THE PUREWICKTM FEMALE EXTERNAL CATHETER HAVING FREQUENT EPISODES OF BOWEL INCONTINENCE WITHOUT A FECAL MANAGEMENT SYSTEM IN PLACE EXPERIENCING SKIN IRRITATION OR BREAKDOWN AT THE SITE EXPERIENCING MODERATE/HEAVY MENSTRUATION AND CANNOT USE A TAMPON DO NOT USE BARRIER CREAM ON THE PERINEUM WHEN USING THE PUREWICKTM FEMALE EXTERNAL CATHETER. BARRIER CREAM MAY IMPEDE SUCTION. NOT RECOMMENDED FOR USE ON PATIENTS WITH A KNOWN LATEX ALLERGY. PROCEED WITH CAUTION IN PATIENTS WHO HAVE UNDERGONE RECENT SURGERY OF THE EXTERNAL UROGENITAL TRACT. ALWAYS ASSESS SKIN FOR COMPROMISE AND PERFORM PERINEAL CARE PRIOR TO PLACEMENT OF A NEW PUREWICKTM FEMALE EXTERNAL CATHETER. MAINTAIN SUCTION UNTIL THE PUREWICKTM FEMALE EXTERNAL CATHETER IS FULLY REMOVED FROM THE PATIENT TO AVOID URINE BACKFLOW. RECOMMENDATIONS: PERFORM EACH STEP WITH CLEAN TECHNIQUE. IN THE HOME SETTING, WASH HANDS THOROUGHLY BEFORE DEVICE PLACEMENT. PRIOR TO CONNECTING THE PUREWICKTM FEMALE EXTERNAL CATHETER TO HOSPITAL WALL SUCTION TUBING, VERIFY SUCTION FUNCTION BY COVERING THE OPEN END OF THE SUCTION TUBING WITH ONE HAND AND OBSERVING THE PRESSURE DIAL. IF THE PRESSURE DOES NOT INCREASE WHEN THE LINE IS COVERED, VERIFY THAT THE TUBING IS SECURED, CONNECTED, AND NOT KINKED. ENSURE THE PUREWICKTM FEMALE EXTERNAL CATHETER REMAINS IN THE CORRECT POSITION AFTER TURNING THE PATIENT. REMOVE THE PUREWICKTM FEMALE EXTERNAL CATHETER PRIOR TO AMBULATION. PROPERLY PLACING THE PUREWICKTM FEMALE EXTERNAL CATHETER SNUGLY BETWEEN THE LABIA AND GLUTEUS HOLDS THE PUREWICKTM FEMALE EXTERNAL CATHETER IN PLACE FOR MOST PATIENTS. MESH UNDERWEAR MAY BE USEFUL FOR SECURING THE PUREWICKTM FEMALE EXTERNAL CATHETER FOR SOME PATIENTS. ASSESS DEVICE PLACEMENT AND PATIENT¿S SKIN AT LEAST EVERY 2 HOURS. REPLACE THE PUREWICKTM FEMALE EXTERNAL CATHETER EVERY 8-12 HOURS OR WHEN SOILED WITH FECES OR BLOOD. CHANGE SUCTION TUBING PER HOSPITAL PROTOCOL OR AT LEAST EVERY THIRTY (30) DAYS." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK PACKAGING DID NOT STATE THAT THE PRODUCT CONTAINS LATEX BUT ONLY STATES "CONTAINS DRY NATURAL RUBBER. THE DEVICE WAS NOT USED ON THE PATIENT AND WAS DISCOVERED PRIOR TO USE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUREWICK PACKAGING DID NOT STATE THAT THE PRODUCT CONTAINS LATEX BUT ONLY STATES "CONTAINS DRY NATURAL RUBBER''. THE DEVICE WAS NOT USED ON THE PATIENT AND WAS DISCOVERED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554665 PUREWICK FEMALE EXTERNAL CATHETER PUREWICK DEVICE NZU PUREWICK CORPORATION ¿ 3012224959 UNK 00801741143083

    Patients

    Seq Age Sex Outcome Treatment
    1