BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5467496 · Received February 29, 2016

    Report

    Report Number
    8043817-2016-00022
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    October 1, 2015
    Report Date
    February 10, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ACTUAL PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. DHR WAS REVIEWED PRODUCT (B)(4), LOT D152231 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PIECES, AND IT WAS MANUFACTURED ON 08/20/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION.

    Additional Manufacturer Narrative · 1

    NO ACTUAL PRODUCT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. DHR WAS REVIEWED FOR PRODUCT ORS-300, LOT D152231 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PIECES, AND IT WAS MANUFACTURED ON 08/20/2015. FOLLOW UP #1: LOT 1036221 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE MICROTEK NON STERILE LOTS D152161 AND D152221. THE DHR WAS REVIEWED FOR LOT D152161 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/05/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION THE DHR WAS REVIEWED FOR LOT D152221 AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/11/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. BASED ON THE DEVICE HISTORY RECORD, THE DRAPE WAS MANUFACTURED TO SPECIFICATIONS AND THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A MATERIAL ISSUE. THE NON CONFORMITY COULD NOT BE CONFIRMED BECAUSE A SAMPLE WAS NOT RETURNED.

    Description of Event or Problem · 1

    END USER FOUND A SMALL HOLE ON THE WARMER SIDE OF THE DRAPE AND THE SOLUTION WAS NO LONGER STERILE. THIS WAS NOT REALIZED UNTIL AFTER THE CASE WAS OVER. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    END USER FOUND A SMALL HOLE ON THE WARMER SIDE OF THE DRAPE AND THE SOLUTION WAS NO LONGER STERILE. THIS WAS NOT REALIZED UNTIL AFTER THE CASE WAS OVER. THERE WERE NO PATIENT INJURY OR TREATMENT REPORTED FOR THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122940 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-320N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1