BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6FR 100% SILICONE FOLEY

    MDR report key: 4912570 · Received July 14, 2015

    Report

    Report Number
    8040412-2015-00148
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    June 18, 2015
    Report Date
    June 18, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FGH
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORDS (LOT 12CE14, 11GE32 & 121E40) WERE REVIEWED AND NO ISSUE THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE WAS NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO RELEASE SPECIFICATION. FROM VISUAL OBSERVATION ON THE REPRESENTATIVE SAMPLES, NO ISSUE WAS FOUND. ALL COMPONENTS WERE INTACT AND IN GOOD CONDITION. BASED ON THE REPORT STATEMENT, A CATHETER WAS FOUND BROKEN AT THE JUNCTION OF THE TUBE, A DAY AFTER INSERTION. TO CONFIRM DEVICE IS FUNCTIONING WELL, FUNNEL DETACHMENT TEST WAS CONDUCTED TO DETERMINE THE BONDING STRENGTH BETWEEN FUNNEL AND SHAFT OF THE REPRESENTATIVE SAMPLE. IN ADDITION, (B)(4) PIECES OF PRODUCTION SAMPLES INCLUSIVE OF REPRESENTATIVE SAMPLES WERE PICKED FOR FUNNEL DETACHMENT TEST. BASED ON THE FINDINGS, ALL TESTED SAMPLES MET THE MINIMUM REQUIREMENT OF 7.5N AND NO OTHER FINDINGS WITHIN THE PRODUCT, WHICH COULD HAVE CONTRIBUTED FROM MANUFACTURING PROCESSES. IN THE ABSENCE OF THE ACTUAL SAMPLES, WE COULD NOT CONDUCT FURTHER INVESTIGATION TO ASSOCIATE THE NATURE OF THE FAILURE WITH ANY MANUFACTURING INADEQUACY. THEREFORE THIS COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE SAMPLE HAS BEEN RETURNED TO THE MANUFACTURER HOWEVER THE INVESTIGATION REPORT HAS NOT BEEN SUBMITTED AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE CATHETER WAS PRE-TESTED PER FACILITY PROTOCOL WITHOUT ISSUE BUT A DAY AFTER INSERTION, THE CATHETER BROKE AT THE JUNCTURE OF THE LUMEN AND LUMEN HUB. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    ALLEGED EVENT: THE CATHETER WAS PRE-TESTED PER FACILITY PROTOCOL WITHOUT ISSUE BUT A DAY AFTER INSERTION, THE CATHETER BROKE AT THE JUNCTURE OF THE LUMEN AND LUMEN HUB. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457458 6FR 100% SILICONE FOLEY FOLEY CATHETER FGH TELEFLEX MEDICAL 12CE14

    Patients

    Seq Age Sex Outcome Treatment
    1