BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER

    MDR report key: 11826149 · Received May 14, 2021

    Report

    Report Number
    1018233-2021-02800
    Event Type
    Malfunction
    Date Received
    May 14, 2021
    Date of Event
    April 21, 2021
    Report Date
    December 1, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741046322
    PMA / PMN Number
    K910318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED AS MANUFACTURING-RELATED. ONE SAMPLE CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT WAS NOT USED FOR PATIENT TREATMENT. THE PRODUCT CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), UNUSED EGGSHELL, 3 WAY LATEX FOLEY CATHETER AND DRAINAGE BAG. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THERE SEEMED TO BE A COATING TEAR, WHICH WOULD SEEM TO BE THE RESULT OF THE CATHETER STICKING TO THE BLUE SLEEVE. THIS DOES NOT MEET THE SPECIFICATION AS "COMPONENTS ARE TO BE PRESENT, CORRECT, UNDAMAGED, AND APPROVED BY Q. A. COMPONENTS ARE TO BE ASSEMBLED PER THE LATEST DRAWING." A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "OPERATOR ERROR". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. LABELING REVIEW WAS NOT PERFORMED BECAUSE LABELLING COULD NOT HAVE PREVENTED THE REPORTED FAILURE. CORRECTIONS: D, H. 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 ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETERS HAD TINY HOLES ALONG THE SIDE.

    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 FOLEY CATHETERS HAD TINY HOLES ALONG THE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721244 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® I.C. COMPLETE CARE FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 129414M NGEZ0086 00801741046322

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other