BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-CENTESIS CATHETER DRAINAGE TRAY, 6 FR

    MDR report key: 4330681 · Received December 15, 2014

    Report

    Report Number
    1625685-2014-00141
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    November 21, 2014
    Report Date
    November 21, 2014
    Manufacturer
    CAREFUSION
    Product Code
    GCB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT SAMPLE WAS NOT PROVIDED FOR EVALUATION. THE INVESTIGATION WAS UNABLE TO CONFIRM THE REPORTED FAILURE MODE THROUGH VISUAL INSPECTION OF THE PHOTOGRAPH PROVIDED BY THE CUSTOMER. EXAMINATION OF THE PHOTOGRAPH DID NOT IDENTIFY ANY MANUFACTURING DEFECT OR MALFUNCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. ANY POTENTIAL CONTRIBUTOR COULD NOT BE EVALUATED FURTHER DUE TO A LACK OF INVESTIGATION EVIDENCE. A 24-MONTH REVIEW OF COMPLAINT DATA (11/1/2012 ¿ 10/31/2014) HAS IDENTIFIED THAT THIS FAILURE MODE IS NOT AN ISOLATED EVENT. A REVIEW OF ALL METHODS AND PERSONNEL USED IN THE ASSEMBLY OF THE DEVICE DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. CONSEQUENTLY, THE INVESTIGATION DETERMINED NO CONTRIBUTION OF MANUFACTURING PERSONNEL TO THE REPORTED COMPLAINT FAILURE MODE EXISTS. A THOROUGH REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE CATHETER VALVE ASSEMBLY IS SUPPLIED BY AN EXTERNAL VENDOR ((B)(4)) AND IS NOT ALTERED BY (B)(4) PRIOR TO ASSEMBLY INTO THE FINISHED TRAY. CONSEQUENTLY, THE INVESTIGATION DETERMINED NO CONTRIBUTION OF THE MANUFACTURING PROCESSES TO THE REPORTED COMPLAINT FAILURE MODE EXISTS.

    Description of Event or Problem · 1

    MEDICAL SPECIALTIES - LEAK CUSTOMER STATED "CATHETER HAD AIR LEAK, SAME ISSUE HAS HAPPENED MULTIPLE TIMES OVER THE PAST FEW MONTHS. WHEN COVERING IT UP WITH A FINGER THE LEAK STOPPED. THEY TRIED TO USE TAPE, BUT UNSUCCESSFUL. (B)(6) 2014 ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER;   THE ISSUE HAPPENED DURING PATIENT USE. THERE WAS NO HARM TO THE PATIENT. WE WERE DOING A PARACENTESIS. THE PROCEDURE WAS COMPLETED, WE JUST HAD TO ALTER THE CONNECTION TO THE VACUTAINER BOTTLES. (B)(6) 2014 CLARIFICATION OF THE ALTERING OF THE CONNECTION--THEY HAD TO REMOVE TUBING WITH THE VALVE ON IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821401 SAFE-T-CENTESIS CATHETER DRAINAGE TRAY, 6 FR SAFE-T-CENTESIS CATHETER DRAINAGE TRAY, 6 FR GCB CAREFUSION PIG1260T 0000687244

    Patients

    Seq Age Sex Outcome Treatment
    1 Other