BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY

    MDR report key: 8335091 · Received February 13, 2019

    Report

    Report Number
    1018233-2019-00757
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Report Date
    May 6, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741073984
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING) SURESTEP TRAY. IT WAS NOTED THAT THE LUBRICATION SYRINGE HAD A 2.50 SQ MM DARK GREEN FOREIGN MATERIAL WITHIN THE LUBRICANT AND WAS PARTIALLY CHANGING THE LUBRICANT COLOR TO YELLOW. FOREIGN MATERIAL OF AN AGGREGATE TOTAL AREA EXCEEDING 0.6 SQ. MM IS OUT OF SPECIFICATION. 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: ¿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 PATIENT RECORD PROPER TECHNIQUES FOR URINARY CATHETER MAINTENANCE ¿ 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 (E.G., PRIOR TO TRANSPORT) USING A SEPARATE, CLEAN COLLECTION CONTAINER FOR EACH PATIENT ¿ ROUTINE HYGIENE (E.G., CLEANSING OF THE MEATAL SURFACE DURING DAILY BATHING OR SHOWERING) IS APPROPRIATE ¿ LEAVE FOLEY CATHETER IN PLACE ONLY AS LONG AS NEEDED"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE INSIDE OF THE SURESTEP FOLEY TRAY CONTAINED BLACK CONTAMINATED MATERIAL INSIDE OF IT.

    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 SYRINGE INSIDE OF THE SURESTEP FOLEY TRAY CONTAINED BLACK CONTAMINATED MATERIAL INSIDE OF IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131139 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® ALL- SILICONE FOLEY CATHETER TRAY SURESTEP FOLEY TRAY EZL C.R. BARD, INC. (COVINGTON) -1018233 A897516 UNK 00801741073984

    Patients

    Seq Age Sex Outcome Treatment
    1