BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5565225 · Received April 8, 2016

    Report

    Report Number
    8043817-2016-00028
    Event Type
    Malfunction
    Date Received
    April 8, 2016
    Report Date
    March 10, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K021288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR WAS REVIEWED AND IT WAS SEEN THAT THIS LOT HAD 4800 PCS AND IT WAS MANUFACTURED ON 7/10/2015. NO DEFECT WAS REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1: LOT 1043776 WAS REPORTED IN THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO MICROTEK NONSTERILE LOTS D152781 AND D152751 THE DHR WAS REVIEWED FOR LOT D152781 AND IT WAS SEEN THAT THIS LOT HAD 4800PCS AND WAS MANUFACTURED ON 10/5/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. THE DHR WAS REVIEWED FOR LOT D152751 AND IT WAS SEEN THAT THIS LOT HAD 4800PCS AND IT WAS MANUFACTURED ON 10/2/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING, OR FINAL INSPECTION. SAMPLES WERE RETURNED ON 3/31/16 FROM LOT 1043776. THE REPORTED DEFECT WAS NOT OBSERVED IN THE RETURNED SAMPLES. AFTER PROCESS EVALUATION NO POSSIBLE ROOT CAUSE FOR THE DEFECT REPORTED COULD BE IDENTIFIED. ALSO, THE DEFECT COULD NOT BE REPLICATED AS NO DEFECTIVE SAMPLE WAS RETURNED FOR EVALUATION. THIS COMPLAINT IS CONSIDERED AN ISOLATED INCIDENT.

    Additional Manufacturer Narrative · 1

    DHR WAS REVIEWED AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 7/10/2015. NO DEFECT WAS REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. SINCE NO DEVICE WAS RETURNED FOR ANALYSIS/REVIEW, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER IS REPORTING THAT THEY USED ONE IN A WARMER FOR A SURGICAL CASE. HAD LAP SPONGES AND ONE SMOOTH BOTTOM PLASTIC BOWL IN WARMER FOR A 3 HOUR CASE. AT THE END OF THE CASE THE CUSTOMER REMOVED THE LAPS AND BOWL, GATHERED SIDE TO TAKE WATER IN THE DRAPE TO THE SINK. BEFORE DUMPING THE CONTENTS THE CUSTOMER NOTICED IT WAS DRIPPING, THEY DRIED THE BOTTOM OF THE DRAPE STILL HOLDING THE WATER AND WAITED A SMALL AMOUNT OF TIME NOTICING IT WAS DRIPPING REALLY SLOWLY. THUS THERE WAS A SMALL HOLE IN THE DRAPE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER IS REPORTING THAT THEY USED ONE IN A WARMER FOR A SURGICAL CASE. HAD LAP SPONGES AND ONE SMOOTH BOTTOM PLASTIC BOWL IN WARMER FOR A 3 HOUR CASE. AT THE END OF THE CASE THE CUSTOMER REMOVED THE LAPS AND BOWL, GATHERED SIDE TO TAKE WATER IN THE DRAPE TO THE SINK. BEFORE DUMPING CONTENTS, THE CUSTOMER NOTICED IT WAS DRIPPING. THEY DRIED THE BOTTOM OF THE DRAPE STILL HOLDING THE WATER AND WAITED A SMALL AMOUNT OF TIME NOTICING IT WAS DRIPPING REALLY SLOWLY. THUS THERE WAS A SMALL HOLE IN THE DRAPE. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220696 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-300N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1