BEUDAMED
    FDA Adverse Event Death Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 10906514 · Received November 25, 2020

    Report

    Report Number
    1018233-2020-21187
    Event Type
    Death
    Date Received
    November 25, 2020
    Date of Event
    September 17, 2020
    Report Date
    February 24, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    NZU
    UDI-DI
    00801741189050
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE DUE TO SKIN IRRITATION OR DERMATITIS OR MINOR BLISTERING APPEARANCE OR SKIN TEARS OR SKIN LESIONS. IT WAS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT USED FOR UROLOGICAL CARE. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER WAS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CONTRAINDICATIONS: PATIENTS WITH URINARY RETENTION. WARNINGS: NEVER INSERT THE PUREWICK FEMALE EXTERNAL CATHETER INTO VAGINA, ANAL CANAL OR OTHER BODY CAVITIES. FOR EXTERNAL USE ONLY. DO NOT USE PUREWICK 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 PUREWICK FEMALE EXTERNAL CATHETER AGAINST THE SKIN DURING PLACEMENT OR REMOVAL. DISCONTINUE USE IF AN ALLERGIC REACTION OCCURS. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USE INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY OR ILLNESS OF THE PATIENT. 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 PUREWICK 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 PUREWICK FEMALE EXTERNAL CATHETER. BARRIER CREAM MAY IMPEDE SUCTION. NOT RECOMMENDED FOR USE ON 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 PUREWICK FEMALE EXTERNAL CATHETER. MAINTAIN SUCTION UNTIL THE PUREWICK FEMALE EXTERNAL CATHETER IS FULLY REMOVED FROM HE PATIENT TO AVOID URINE BACK FLOW. RECOMMENDATIONS: PERFORM EACH STEP WITH CLEAN TECHNIQUE. N THE HOME SETTING, WASH HANDS THOROUGHLY BEFORE DEVICE PLACEMENT. PRIOR TO CONNECTING THE PUREWICK 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 PUREWICK FEMALE EXTERNAL CATHETER REMAINS IN THE CORRECT POSITION AFTER TURNING THE PATIENT. REMOVE THE PUREWICK FEMALE EXTERNAL CATHETER PRIOR TO AMBULATION. PROPERLY PLACING THE PUREWICK FEMALE EXTERNAL CATHETER SNUGLY BETWEEN THE LABIA AND GLUTEUS HOLDS THE PUREWICK FEMALE EXTERNAL CATHETER IN PLACE FOR MOST PATIENTS. MESH UNDERWEAR MAY BE USEFUL FOR SECURING THE PUREWICK FEMALE EXTERNAL CATHETER FOR SOME PATIENTS. ASSESS DEVICE PLACEMENT AND PATIENT'S SKIN AT LEAST EVERY 2 HOURS. REPLACE THE PUREWICK FEMALE EXTERNAL CATHETER EVERY 8-12 HOURS OR WHEN SOILED WITH FECES OR BLOOD. IF USING WALL SUCTION, CHANGE SUCTION TUBING PER HOSPITAL PROTOCOL OR AT LEAST EVERY THIRTY (30) DAYS. IF USING PUREWICK URINE COLLECTION SYSTEM, REPLACE ACCESSORIES PER PUREWICK URINE COLLECTION SYSTEM USER GUIDE.". CORRECTION: B, D, E. 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT USING THE PUREWICK DEVICE DEVELOPED A URINARY TRACT INFECTION. THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY DIED. THE INFORMATION WAS REPORTED BY THE PATIENT CAREGIVER ON AN E SURVEY REGARDING THE PUREWICK SYSTEM. THE DEVICE WAS USED FOR LESS THAN THREE MONTHS. THE PATIENT WAS IMMOBILE AND UNABLE TO INDEPENDENTLY MOVE THEIR BODY OR LOWER EXTREMITIES. IN ADDITION TO USING THE PUREWICK DEVICE ADULT DIAPERS AND ABSORBENT PADS WERE USED. THE CLINICAL FOLLOW UP ATTEMPTS WERE MADE VIA PHONE ON 19NOV2020 AND 20NOV2020 TO THE CAREGIVER TO OBTAIN ADDITIONAL INFORMATION INCLUDING THE CAUSE OF DEATH, HOWEVER NO RESPONSE HAS BEEN RECEIVED. AN ADDITIONAL FOLLOW-UP ATTEMPT WAS MADE VIA EMAIL ON 20NOV2020 AND A PHONE CALL ON 23NOV2020. DESPITE GOOD FAITH EFFORTS NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    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 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT USING THE PUREWICK DEVICE DEVELOPED A URINARY TRACT INFECTION. THE PATIENT WAS HOSPITALIZED AND SUBSEQUENTLY DIED. THE INFORMATION WAS REPORTED BY THE PATIENTS CAREGIVER ON AN E-SURVEY REGARDING THE PUREWICK SYSTEM. THE DEVICE WAS USED FOR LESS THAN THREE MONTHS. THE PATIENT WAS IMMOBILE AND UNABLE TO INDEPENDENTLY MOVE THEIR BODY OR LOWER EXTREMITIES. IN ADDITION TO USING THE PUREWICK DEVICE, ADULT DIAPERS AND ABSORBENT PADS WERE USED. CLINICAL FOLLOW-UP ATTEMPTS WERE MADE VIA PHONE ON (B)(6) 2020 AND (B)(6) 2020 TO THE CAREGIVER TO OBTAIN ADDITIONAL INFORMATION, INCLUDING CAUSE OF DEATH, HOWEVER, NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. AN ADDITIONAL FOLLOW-UP ATTEMPT WAS MADE VIA EMAIL ON (B)(6) 2020 AND A PHONE CALL ON (B)(6) 2020. DESPITE GOOD FAITH EFFORTS, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1364326 PUREWICK FEMALE EXTERNAL CATHETER PUREWICK FEMALE EXTERNAL CATHETER NZU C.R. BARD, INC. (COVINGTON) -1018233 PWFX30 UNK 00801741189050

    Patients

    Seq Age Sex Outcome Treatment
    1 Death
    2 Death