BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER, 400 SERIES 8 FR

    MDR report key: 5921436 · Received September 1, 2016

    Report

    Report Number
    2320762-2016-00016
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 2, 2016
    Report Date
    December 6, 2016
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EYC
    PMA / PMN Number
    K041416
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED REPORTING THAT A FOLEY CATHETER WITH A TEMPERATURE SENSOR (81-080408) FAILED DURING USE. THE CUSTOMER REPORTED PATIENT SUFFERED FROM URINE RETENTION. THIS REPORT IS ONE OF SEVEN TOTAL FILED BY THE REPORTING CUSTOMER IN REFERENCE TO THE FINISHED GOOD NUMBER. ACCORDING TO THE INITIAL COMPLAINT REPORT, THESE INCIDENTS OCCURRED OVER A PERIOD OF SEVERAL MONTHS, AND THE CUSTOMER CHOSE TO FILE THEM AT ONE TIME IN A BATCH. NO LOT NUMBERS WERE PROVIDED, AND A SAMPLE WAS AVAILABLE FOR ONLY ONE OF THE SEVEN REPORTED INCIDENTS. FOR THIS INCIDENT, NEITHER A LOT NUMBER NOR DEFECTIVE SAMPLE WAS AVAILABLE. A SHIPPING INQUIRY BY BOX IDENTIFICATION SHOWED THAT FOUR CASES OF FINISHED GOOD 81-080408 WERE ORDERED BY THE REPORTING CUSTOMER IN 2013 AND SHIPPED ON (B)(94) 2013. THE LOT NUMBER SHIPPED TO THE CUSTOMER WAS 32608900, WHICH WAS MANUFACTURED JULY 2, 2013. REVIEW OF THIS WORK ORDER SHOWS NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE FINISHED GOOD ASSEMBLY CONSISTS OF THE FOLLOWING RAW MATERIALS THAT ARE ASSEMBLED AS DETAILED BELOW: RAW MATERIAL PART NUMBER 74-12088W (FOLEY CATHETER WIRE SUPPLIED BY (B)(4)) IS RECEIVED AT THE MANUFACTURING PLANT. AFTER RECEIVING, A CONNECTOR IS MOLDED TO THE WIRE SET AND A CONTINUITY TEST IS CONDUCTED TO ENSURE THE THERMISTOR CHIP HAS NOT HAD ANY AFFECTATION. THE RAW MATERIAL IS CONVERTED TO PART NUMBER 74-12088CR (MOLDED FOLEY CATHETER WIRE SET) AND SHIPPED TO DEGANIA SILICONE. ONCE DEGANIA SILICONE HAS RECEIVED THE PRODUCT, THE PART IS CONVERTED INTO PART NUMBER 74-12089 (FOLEY CATHETER 8 FR) AND SHIPPED TO THE PLANT IN NEW TAZEWELL FOR PACKAGING. IT IS HERE THE PART NUMBER IS CONVERTED TO THE FINISHED GOOD PART NUMBER OF 81-080408. THE SILICONE CATHETER PORTION OF THIS DEVICE IS SUPPLIED BY DEGANIA SILICONE. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE VENDOR ON (B)(4) 2016. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: THE CATHETER IS SUPPLIED BY (B)(4), AND THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). IN SCAR RESPONSE, (B)(4) STATED THAT WITH THE AVAILABLE INFORMATION, IT IS UNAVAILABLE TO PERFORM A PROPER INVESTIGATION AND DEFINE A ROOT CAUSE. THE SAMPLES AND LOT NUMBER INFORMATION WERE NOT PROVIDED. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) INDICATED A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED REPORTING THAT A FOLEY CATHETER WITH A TEMPERATURE SENSOR (81-080408) FAILED DURING USE. THE CUSTOMER REPORTED PATIENT SUFFERED FROM URINE RETENTION. THIS REPORT IS ONE OF SEVEN TOTAL FILED BY THE REPORTING CUSTOMER IN REFERENCE TO THE FINISHED GOOD NUMBER. ACCORDING TO THE INITIAL COMPLAINT REPORT, THESE INCIDENTS OCCURRED OVER A PERIOD OF SEVERAL MONTHS, AND THE CUSTOMER CHOSE TO FILE THEM AT ONE TIME IN A BATCH. NO LOT NUMBERS WERE PROVIDED, AND A SAMPLE WAS AVAILABLE FOR ONLY ONE OF THE SEVEN REPORTED INCIDENTS. FOR THIS INCIDENT, NEITHER A LOT NUMBER NOR DEFECTIVE SAMPLE WAS AVAILABLE. A SHIPPING INQUIRY BY BOX IDENTIFICATION SHOWED THAT FOUR CASES OF FINISHED GOOD 81-080408 WERE ORDERED BY THE REPORTING CUSTOMER IN 2013 AND SHIPPED ON JULY 11, 2013. THE LOT NUMBER SHIPPED TO THE CUSTOMER WAS 32608900, WHICH WAS MANUFACTURED JULY 2, 2013. REVIEW OF THIS WORK ORDER SHOWS NO DISCREPANCIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE FINISHED GOOD ASSEMBLY CONSISTS OF THE FOLLOWING RAW MATERIALS THAT ARE ASSEMBLED AS DETAILED BELOW: * RAW MATERIAL PART NUMBER 74-12088W (FOLEY CATHETER WIRE SUPPLIED BY (B)(4)) IS RECEIVED AT THE MANUFACTURING PLANT. AFTER RECEIVING, A CONNECTOR IS MOLDED TO THE WIRE SET AND A CONTINUITY TEST IS CONDUCTED TO ENSURE THE THERMISTOR CHIP HAS NOT HAD ANY AFFECTATION. THE RAW MATERIAL IS CONVERTED TO PART NUMBER 74-12088CR (MOLDED FOLEY CATHETER WIRE SET) AND SHIPPED TO (B)(4). * ONCE (B)(4) HAS RECEIVED THE PRODUCT, THE PART IS CONVERTED INTO PART NUMBER 74-12089 (FOLEY CATHETER 8 FR) AND SHIPPED TO THE PLANT IN (B)(4) FOR PACKAGING. IT IS HERE THE PART NUMBER IS CONVERTED TO THE FINISHED GOOD PART NUMBER OF 81-080408. THE TWO MOST RECENT WORK ORDERS FOR RAW MATERIAL PART 74-12088CR WERE REVIEWED AND NO REJECTS WERE REPORTED DURING THE MANUFACTURING PROCESS. THE LAST SHIPMENT OF RAW MATERIAL 74-12088CR WAS SENT TO (B)(4) IN 2014. BECAUSE THE CATHETER IS SUPPLIED BY (B)(4), A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE VENDOR ON AUGUST 29, 2016, AND A DUE DATE OF OCTOBER 12, 2016, WAS ASSIGNED. A RESPONSE WAS NOT RECEIVED ON THIS DATE. FOLLOW UP ATTEMPTS WERE MADE AND A RESPONSE WAS RECEIVED NOVEMBER 25, 2016. THE FAILURE MODE AND EFFECTS ANALYSIS (FMEA) WAS REVIEWED AND IT WAS DETERMINED NO UPDATES ARE NEEDED AT THIS TIME. PREVENTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) INDICATED A PREVENTIVE ACTION HAS NOT BEEN TAKEN AT THIS TIME. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED URINE RETENTION WHILE USING A FOLEY CATHETER WITH A TEMPERATURE SENSOR. THE PATIENT'S BELLY WAS FELT AND FOUND TO BE HARD NEAR THE BLADDER. THE PATIENT COMPLAINED OF BELLY PAIN. THE CATHETER WAS FLUSHED WITH SOME RESISTANCE AT FIRST, BUT AFTER THAT, THE URINE COULD BE EASILY SUCTIONED WITH A SYRINGE. THE CATHETER WAS ULTIMATELY REPLACED WITH A NEW DEVICE.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED URINE RETENTION WHILE USING A FOLEY CATHETER WITH A TEMPERATURE SENSOR. THE PATIENT'S BELLY WAS FELT AND FOUND TO BE HARD NEAR THE BLADDER. THE PATIENT COMPLAINED OF BELLY PAIN. THE CATHETER WAS FLUSHED WITH SOME RESISTANCE AT FIRST, BUT AFTER THAT, THE URINE COULD BE EASILY SUCTIONED WITH A SYRINGE. THE CATHETER WAS ULTIMATELY REPLACED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573380 FOLEY CATHETER, 400 SERIES 8 FR CATHETER, UPPER URINARY TRACT EYC DEROYAL INDUSTRIES, INC. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1