BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 11786384 · Received May 6, 2021

    Report

    Report Number
    1018233-2021-02637
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 14, 2021
    Report Date
    August 13, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741189050
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. 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: 'INSTRUCTIONS FOR USE SETUP: 1. CONNECT THE CANISTER TO WALL SUCTION AND SET TO A MINIMUM OF 40MMHG CONTINUOUS SUCTION. ALWAYS USE THE MINIMUM AMOUNT OF SUCTION NECESSARY. IF USING THE DRYDOCTM VACUUM STATION, CONNECT THE CANISTER TO THE UNIT AND TURN THE UNIT ON. PLEASE CONSULT THE DRYDOCTM VACUUM STATION USER GUIDE FOR FURTHER INFORMATION. 2. USING THE STANDARD SUCTION TUBING, CONNECT THE PUREWICKTM FEMALE EXTERNAL CATHETER TO THE COLLECTION CANISTER. PERI-CARE AND PLACEMENT: 3. PERFORM PERINEAL CARE AND ASSESS SKIN INTEGRITY (DOCUMENT PER HOSPITAL PROTOCOL). SEPARATE LEGS, GLUTEUS MUSCLES, AND LABIA. PALPATE PUBIC BONE AS ANATOMICAL MARKER. 4. WITH SOFT GAUZE SIDE FACING PATIENT, ALIGN DISTAL END OF THE PUREWICKTM FEMALE EXTERNAL CATHETER AT GLUTEAL CLEFT. GENTLY TUCK SOFT GAUZE SIDE BETWEEN SEPARATED GLUTEUS AND LABIA. ENSURE THAT THE TOP OF THE GAUZE IS ALIGNED WITH THE PUBIC BONE. SLOWLY PLACE LEGS BACK TOGETHER ONCE THE PUREWICKTM FEMALE EXTERNAL CATHETER IS POSITIONED. NOTES: PATIENT CAN BE POSITIONED ON BACK, SIDE LYING, FROG LEGGED, OR LYING ON BACK WITH KNEES BENT AND THIGHS APART (LITHOTOMY POSITION) PRIOR TO DEVICE PLACEMENT. REMOVAL: 5. TO REMOVE THE PUREWICKTM FEMALE EXTERNAL CATHETER, FULLY SEPARATE THE LEGS, GLUTEUS, AND LABIA. TO AVOID POTENTIAL SKIN INJURY UPON REMOVAL, GENTLY PULL THE PUREWICKTM FEMALE EXTERNAL CATHETER DIRECTLY OUTWARD. ENSURE SUCTION IS MAINTAINED WHILE REMOVING THE PUREWICKTM FEMALE EXTERNAL CATHETER. AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. MAINTENANCE: 6. REPLACE THE PUREWICKTM FEMALE EXTERNAL CATHETER AT LEAST EVERY 8-12 HOURS OR IF SOILED WITH FECES OR BLOOD. ALWAYS ASSESS SKIN FOR COMPROMISE AND PERFORM PERINEAL CARE PRIOR TO PLACEMENT OF A NEW PUREWICKTM FEMALE EXTERNAL CATHETER. INDICATIONS FOR USE: ¿ THE PUREWICKTM FEMALE EXTERNAL CATHETER IS INTENDED FOR NON-INVASIVE URINE OUTPUT MANAGEMENT IN FEMALE PATIENTS. CONTRADICTIONS: ¿ PATIENT WITH URINARY RETENTION. 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 COMPROMISE 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. ¿ 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 IF 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 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUREWICK FEMALE EXTERNAL CATHETER CAUSED BLEEDING AND DISCOMFORT. THROUGH DISCUSSION, REPRESENTATIVE DETERMINED THAT THE PATIENT WAS INSERTING THE WICK. THE REPRESENTATIVE PROVIDED WICK PREPARATION AND PLACEMENT INSTRUCTIONS.

    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 FEMALE EXTERNAL CATHETER CAUSED BLEEDING AND DISCOMFORT. THROUGH DISCUSSION, REPRESENTATIVE DETERMINED THE PATIENT WAS INSERTING THE WICK AND PROVIDED WICK PREPARATION AND PLACEMENT INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680084 PUREWICK FEMALE EXTERNAL CATHETER PUREWICK FEMALE EXTERNAL CATHETER NZU C.R. BARD, INC. (COVINGTON) -1018233 PWFX30 MYEW3561 00801741189050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other