BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUREWICK FEMALE EXTERNAL CATHETER

    MDR report key: 14704135 · Received June 15, 2022

    Report

    Report Number
    1018233-2022-04667
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 26, 2022
    Report Date
    August 29, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "INADEQUATE MATERIAL SELECTION - MATERIALS OF CONSTRUCTION ARE NOT BIOCOMPATIBLE OR MATERIAL SURFACE IS ROUGH, ABRASIVE OR UNCOMFORTABLE ". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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: "INDICATION FOR USE: THE PURE-WICK FEMALE EXTERNAL CATHETER IS INTENDED FOR NON-INVASIVE URINE OUTPUT MANAGEMENT IN FEMALE PATIENTS. CONTRAINDICATIONS: PATIENTS WITH URINARY RETENTION. WARNINGS: DO NOT USE THE PURE-WICK 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 PURE-WICK FEMALE EXTERNAL CATHETER AGAINST THE SKIN DURING PLACEMENT OR REMOVAL. NEVER INSERT THE PURE-WICK 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 PURE-WICK 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 PURE-WICKFEMALE 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 PURE-WICK FEMALE EXTERNAL CATHETER. MAINTAIN SUCTION UNTIL THE PURE-WICK FEMALE EXTERNAL CATHETER IS FULLY REMOVED FROM THE PATIENT TO AVOID URINE BACKFLOW." 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 DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STOPPED USING THE PUREWICK FEMALE EXTERNAL CATHETER DUE TO GETTING URINARY TRACT INFECTIONS FROM ITS USE. THE PATIENT HAD BEEN USING THIS PRODUCT FOR MORE THAN 90 DAYS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT STOPPED USING THE PUREWICK FEMALE EXTERNAL CATHETER DUE TO GETTING URINARY TRACT INFECTIONS FROM ITS USE. THE PATIENT HAD BEEN USING THIS PRODUCT FOR MORE THAN 90 DAYS. IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE URINARY TRACT INFECTION AT THIS TIME AND MEDICAL INTERVENTION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795988 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 Female Other