BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GPC396 GENERAL PURPOSE PROBE COVER

    MDR report key: 5544217 · Received April 4, 2016

    Report

    Report Number
    8043817-2016-00027
    Event Type
    Malfunction
    Date Received
    April 4, 2016
    Report Date
    March 4, 2016
    Manufacturer
    MICROTEK DOMINICANA, S.A.
    Product Code
    KKX
    PMA / PMN Number
    K882724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/02/2014. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. NO 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.

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) WAS REVIEWED AD IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 05/02/2014. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. NO 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. FOLLOW UP #1. AN ADDITIONAL REPORT OF (B)(4) INCIDENTS FROM LOT D152251 WAS RECEIVED ON MARCH 10, 2016. SAMPLES WERE RETURNED ON 4/6/2016 FOR LOT D141221. THIS SAMPLE WAS A PIECE OF THE LOT AFFECTED, BUT NOT THE ACTUAL DEVICE THAT FAILED. THE REPORTED DEFECT WAS NOT OBSERVED IN THE RETURNED SAMPLE. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR LOT D152251 IT WAS SEEN THAT THIS LOT HAD (B)(4) PCS AND IT WAS MANUFACTURED ON 08/13/2015. NO DEFECTS WERE REPORTED IN PROCESS, PACKAGING OR FINAL INSPECTION. NO PRODUCT OF THIS LOT HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR REVIEW. 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 ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO SEPARATE INSTANCES WHERE BLOOD WAS FOUND ON THE INSIDE OF THE PROBE COVER FOLLOWING PROCEDURES. THE CUSTOMER FILLED ONE OF THE PROBE COVERS WITH WATER AND OBSERVED WATER SPURTING OUT OF THE END. THERE WERE 2 TINY PINHOLES AND THE END OF THE PROBE COVER. IT DID NOT APPEAR THAT THE WATER WAS ESCAPING BY WAY OF A FAILED SEAM. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TWO SEPARATE INSTANCES WHERE BLOOD WAS FOUND ON THE INSIDE OF THE PROBE COVER FOLLOWING PROCEDURES. THE CUSTOMER FILLED ONE OF THE PROBE COVERS WITH WATER AND OBSERVED WATER SPURTING OUT OF THE END. THERE WERE 2 TINY PINHOLES AND THE END OF THE PROBE COVER. IT DID NOT APPEAR THAT THE WATER WAS ESCAPING BY WAY OF A FAILED SEAM. THERE WAS NO PATIENT INJURY AND TREATMENT REPORTED OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202171 GPC396 GENERAL PURPOSE PROBE COVER GENERAL PURPOSE PROBE COVER KKX MICROTEK DOMINICANA, S.A. GPC396 D141221

    Patients

    Seq Age Sex Outcome Treatment
    1