BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORS-100 FLUID WARMER DRAPE

    MDR report key: 7397224 · Received April 4, 2018

    Report

    Report Number
    8043817-2018-00009
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Report Date
    April 13, 2018
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    UDI-DI
    00748426106912
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS AVAILABLE FOR EVALUATION. MULTIPLE LOTS WERE PROVIDED BY THE END USER: D171869, D172279, D171859, D172029, D172399. THE DHRS WERE REVIEWED AND IT WAS NOTICED THAT: D172279: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 08/15/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D171859: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/06/2017 TO 07/07/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D172029: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 07/21/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D172399: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 08/28/2017 TO 08/29/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D171869: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/07/2017 TO 07/10/2017. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD REVIEW, THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED SINCE NO SAMPLE WAS RETURNED FOR REVIEW. BECAUSE NO SAMPLE WAS RETURNED THE NON CONFORMITY COULD NOT BE CONFIRMED AND THE ROOT CAUSE FOR THIS INVESTIGATION IS UNDETERMINED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION OR SAMPLE BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS AVAILABLE FOR EVALUATION. MULTIPLE LOTS WERE PROVIDED BY THE END USER: D171869, D172279, D171859, D172029, D172399. THE DHRS WERE REVIEWED AND IT WAS NOTICED THAT: D172279: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 08/15/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D171859: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/06/17 TO 07/07/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D172029: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED ON 07/21/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D172399: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 08/28/17 TO 08/29/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. D171869: THIS LOT HAD (B)(4) PCS THAT WERE MANUFACTURED FROM 07/07/17 TO 07/10/17. NO DEFECTS WERE REPORTED DURING QUALITY INSPECTIONS. BASED ON THE DEVICE HISTORY RECORD REVIEW THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED SINCE NO SAMPLE WAS RETURNED FOR REVIEW. BECAUSE NO SAMPLE WAS RETURNED THE NON CONFORMITY COULD NOT BE CONFIRMED AND THE ROOT CAUSE FOR THIS INVESTIGATION IS UNDETERMINED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME. IF ADDITIONAL INFORMATION OR SAMPLE BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. FOLLOW UP 1: SAMPLES RECEIVED FOR EVALUATION. ONLY LOTS D172029, D172279 AND D172399 WERE RETURNED. ONE UNOPENED DRAPE FROM EACH LOT WAS TESTED, DRAPED OVER A WARMER WITH WATER AND NO LEAKS OR HOLES WERE FOUND. BASED ON THE SAMPLE REVIEW THIS DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL PROCESS OR MATERIAL ISSUE. BECAUSE THE UNOPENED SAMPLES RETURNED DIDN'T HAVE ANY HOLES AND THE SAMPLE IN QUESTION WAS NOT RETURNED, THE NON CONFORMITY COULD NOT BE CONFIRMED AND THE ROOT CAUSE FOR THIS INVESTIGATION IS UNDETERMINED. NO ADDITIONAL ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT DRAPE HAD PINHOLE PRICK IN IT THAT WAS FOUND AFTER THE CASE ENDED. DRAPE CAME FROM ONE OF LOT NUMBERS ABOVE, BUT THEY THREW AWAY THE DRAPE ITSELF. NEED AN ANALYSIS OF LOT NUMBERS TO MAKE SURE THERE'S AREN'T COMPROMISED. THE OR NOTED "THE PATIENT HAD A POST OPERATIVE INFECTION THAT WAS DUE TO A FEEDING TUBE AND UNLIKELY DUE TO THE PRODUCT DEFICIENCY."

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED THAT DRAPE HAD PINHOLE PRICK IN IT THAT WAS FOUND AFTER THE CASE ENDED. DRAPE CAME FROM ONE OF LOT NUMBERS ABOVE, BUT THEY THREW AWAY THE DRAPE ITSELF. NEED AN ANALYSIS OF LOT NUMBERS TO MAKE SURE THERE'S AREN'T COMPROMISED. THE OR NOTED "THE PATIENT HAD A POST OPERATIVE INFECTION THAT WAS DUE TO A FEEDING TUBE AND UNLIKELY DUE TO THE PRODUCT DEFICIENCY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239698 ORS-100 FLUID WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-100 SEE H10 00748426106912

    Patients

    Seq Age Sex Outcome Treatment
    1