BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER AND GLOVE SUCTION KIT WITH SOLUTION CONTAINER, TWO VINYL GLOVES, TWO EY

    MDR report key: 7505254 · Received May 10, 2018

    Report

    Report Number
    1018233-2018-01633
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Report Date
    June 18, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED ISSUE WAS CONFIRMED AS MANUFACTURING RELATED. VISUAL INSPECTION NOTED THE 8 SAMPLES WERE OPENED AND NOTED THAT CATHETER CONFIGURATION DID NOT MATCH THE CURRENT CONFIGURATION OF CATALOG 0140080. THE 8FR CATHETER REQUIRES PRINT MARKS; HOWEVER, THE PLASTIC SLEEVE OVER THE CATHETER IS NOT REQUIRED. THE DIMENSIONAL ASSESSMENT FOUND THAT THE SAMPLES MEASURED 14FR. CAPA NG-CAPA-(B)(4) WAS INITIATED ON 10/20/2017. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND A POSSIBLE MANUFACTURING ISSUE(S) THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿1 UNIT NOT MADE WITH NATURAL RUBBER LATEX. DO NOT USE IF PACKAGE IS DAMAGE. SINGLE USE. DO NOT RESTERILIZE. RX ONLY".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRACHEAL SUCTION CATHETER WAS LARGER IN DIAMETER AND MISSING THE DEPTH MARKINGS AS INDICATED BY THE PACKAGING COMPARED TO THE SAME PRODUCT WITH A DIFFERENT LOT NUMBER. THE CUSTOMER ATTEMPTED TO USE THE CATHETER ON THE PATIENT, HOWEVER IT DID NOT FIT INTO THE OPENING. THE CATHETER WAS REPLACED.

    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 BARD 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 BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRACHEAL SUCTION CATHETER WAS LARGER IN DIAMETER AND MISSING THE DEPTH MARKINGS AS INDICATED BY THE PACKAGING COMPARED TO THE SAME PRODUCT WITH A DIFFERENT LOT NUMBER. THE CUSTOMER ATTEMPTED TO USE THE CATHETER ON THE PATIENT, HOWEVER IT DID NOT FIT INTO THE OPENING. THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347768 CATHETER AND GLOVE SUCTION KIT WITH SOLUTION CONTAINER, TWO VINYL GLOVES, TWO EY SUCTION CATHETER BSY C.R. BARD, INC. (COVINGTON) -1018233 NGBQ3835

    Patients

    Seq Age Sex Outcome Treatment
    1