BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WARMER DRAPE

    MDR report key: 5348446 · Received January 6, 2016

    Report

    Report Number
    8043817-2016-00002
    Event Type
    Malfunction
    Date Received
    January 6, 2016
    Date of Event
    October 26, 2015
    Report Date
    November 5, 2015
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    LHC
    PMA / PMN Number
    K142080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED AND IT WAS SHOWN THAT - ORS 320, LOT D 151181 HAD (B)(4) PIECES MANUFACTURED ON 04/28/2015. THERE WERE NO DEFECTS IN THE PROCESSES, PACKAGING OR FINAL INSPECTION (NOTE: THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS). SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED AND IT WAS SHOWN THAT ORS -320 LOT D151181 HAD (B)(4) PIECES AND WAS MANUFACTURED ON 04/28/2015. THERE WERE NO DEFECTS IN THE PROCESSES, PACKAGING OR FINAL INSPECTION (NOTE: THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS). SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP #1: LOT 1037253 WAS REPORTED FOR THIS COMPLAINT. THIS IS THE STERILE LOT FROM MEDICAL ACTION WHICH CORRESPONDS TO THE NON STERILE LOTS FROM MICROTEK: D1518181, D151611, D151941, D151331, D152221, D151451, D151381, D151391, D151351, D152161, D151601. THE DHR WAS REVIEWED FOR LOT D151181. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 04/28/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151451. THIS LOT HAD (B)(4) PCS AND WAS MANUFACTURED ON 05/25/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151331. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/13/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151381. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/19/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151391. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/20/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151611. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 06/10/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151941. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 07/14/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D151351. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/18/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. THIS LOT WAS MANUFACTURED IN COMBINED SHIFTS. THE DHR WAS REVIEWED FOR LOT D152161. 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. THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/11/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. LOT D151501 WAS NOT ASSIGNED FOR PRODUCT ORS-320N. BASED ON THE DHR REVIEW THE NON CONFORMITY DOES NOT APPEAR TO BE THE RESULT OF A PERSONNEL, PROCESS OR MATERIAL ISSUE. DUE TO SAMPLE NOT BEING REVIEWED THE NON CONFORMITY COULD NOT BE PHYSICALLY CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER WAS REPORTING THAT THE DRAPE SLUSH WARMER, ORS - 320, 44 X 66 THAT HELD SALINE/ANTIBIOTIC MIXTURE NOTED TO BE WET ON THE BOTTOM AFTER COMPLETION OF CASE. UPON INSPECTION TWO HOLES WERE NOTED ON DRAPE. AN ADDITIONAL ANTIBIOTIC WAS PROVIDED TO PATIENT BY PHYSICIAN.

    Description of Event or Problem · 1

    CUSTOMER WAS REPORTING THAT THE DRAPE SLUSH WARMER, ORS-320 22X66 THAT HELD SALINE/ANTIBIOTIC MIXTURE NOTED TO BE WET ON THE BOTTOM AFTER COMPLETION OF CASE. UPON INSPECTION TWO HOLES WERE NOTED ON THE DRAPE. AN ADDITIONAL ANTIBIOTIC WAS PROVIDED TO PATIENT BY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8612 WARMER DRAPE FLUID WARMING AND SLUSH DRAPES LHC MICROTEK DOMINICANA, S.A. ORS-320N SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1