BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER

    MDR report key: 10219697 · Received July 1, 2020

    Report

    Report Number
    1018233-2020-04206
    Event Type
    Injury
    Date Received
    July 1, 2020
    Report Date
    August 29, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741025228
    PMA / PMN Number
    K040504
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED SINCE THE PROBLEM COULD NOT BE REPRODUCED. THERE WERE NO SPECIFICATIONS FOR THIS EXACT FAILURE, HOWEVER THE REPORTED FAILURE WAS CONSIDERED WITHIN SPECIFICATION BECAUSE THE REPORTED EVENT COULD NOT BE REPRODUCED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED 15 UNOPENED (IN ORIGINAL PACKAGING) SILICONE FOLEY TRAYS. THE CATHETER BALLOONS WERE INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND NO LEAKS WERE OBSERVED. ALL OF THE BALLOONS RESTED FOR 30 MINUTES WITHOUT LEAKS AND PASSIVELY DEFLATED IN WITHOUT ISSUE OR CUFFING, RETURNING 10ML OF SOLUTION. ALL OF THEIR DRAINAGE LUMENS WERE FLUSHED WITH METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML OF DISTILLED WATER) AND DID NOT LEAK. A POTENTIAL ROOT CAUSE COULD NOT BE FOUND SINCE THE REPORTED EVENT WAS UNCONFIRMED. A DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED SINCE THE REPORTED FAILURE WAS UNCONFIRMED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "STERILE UNLESS PACKAGE IS OPENED OR DAMAGED, EXCEPT FOR ANY INDIVIDUALLY PACKAGED COMPONENTS WITHIN THE TRAY WHICH ARE NOT LABELED AS STERILE. THESE COMPONENTS ARE NOT TERMINALLY STERILIZED. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. SINGLE USE ONLY. DO NOT RE-STERILIZE. FOR UROLOGICAL USE ONLY. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER AND MAY CAUSE BALLOON TO BURST. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICES AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. PLEASE CONSULT PRODUCT LABEL AND INSERT FOR ANY INDICATIONS, CONTRAINDICATIONS, HAZARDS, WARNINGS, CAUTIONS AND DIRECTIONS FOR USE. PROPER TECHNIQUES FOR URINARY CATHETER INSERTION PERFORM HAND HYGIENE IMMEDIATELY BEFORE AND AFTER INSERTION INSERT URINARY CATHETERS USING ASEPTIC TECHNIQUE AND STERILE EQUIPMENT USE THE SMALLEST FOLEY CATHETER POSSIBLE, CONSISTENT WITH GOOD DRAINAGE DOCUMENT THE INDICATIONS FOR CATHETER INSERTION, DATE AND TIME OF CATHETER INSERTION, INDIVIDUAL WHO INSERTED CATHETER, AND DATE AND TIME OF CATHETER REMOVAL IN THE PATIENT RECORD * GENERALLY, DRAINAGE IS ACCOMPLISHED BY INSERTING THE CATHETER THROUGH THE URETHRA AND INTO THE BLADDER. HOWEVER, DRAINAGE IS SOMETIMES ACCOMPLISHED BY SUPRAPUBIC OR OTHER PLACEMENT OF THE CATHETER, SUCH AS NEPHROSTOMY TRACT. ¿ TO ASSIST IN HEALING OF OPEN SACRAL OR PERINEAL WOUNDS ¿ PATIENT REQUIRES PROLONGED IMMOBILIZATION ¿ TO IMPROVE COMFORT FOR END OF LIFE CARE ¿ PATIENT HAS ACUTE URINARY RETENTION OR BLADDER OUTLET OBSTRUCTION ¿ NEED FOR ACCURATE URINE OUTPUT MEASUREMENTS ¿ USE FOR SELECTED SURGICAL PROCEDURES SECURE THE FOLEY CATHETER. USE THE STATLOCK® FOLEY STABILIZATION DEVICE IF PROVIDED MAINTAIN A CLOSED DRAINAGE SYSTEM BY UTILIZING PRE-CONNECTED, SEALED CATHETER-TUBING JUNCTIONS MAINTAIN UNOBSTRUCTED URINE FLOW AND KEEP THE CATHETER AND COLLECTION TUBE FREE FROM KINKING KEEP THE COLLECTION BAG BELOW THE LEVEL OF THE BLADDER OR HIPS AT ALL TIMES EMPTY THE COLLECTION BAG REGULARLY USING A SEPARATE, CLEAN COLLECTION CONTAINER FOR EACH PATIENT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE URINE LEAKED FROM THE MEATUS WHILE USING THE FOLEY CATHETER. PER FOLLOW UP WITH COMPLAINANT VIA PHONE ON (B)(6) 2020, THE PATIENT DEVELOPED URINARY TRACT INFECTION AS A RESULT OF THE CATHETER LEAKING. THE INFECTION WAS TREATED WITH ANTIBIOTICS.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE URINE LEAKED FROM THE MEATUS WHILE USING THE FOLEY CATHETER. PER FOLLOW UP WITH COMPLAINANT VIA PHONE ON 06/16/2020, THE PATIENT DEVELOPED URINARY TRACT INFECTION AS A RESULT OF THE CATHETER LEAKING. THE INFECTION WAS TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684102 BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER FOLEY CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 1758SI16 NGEQ1557 00801741025228

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention