BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 7449884 · Received April 22, 2018

    Report

    Report Number
    9680654-2018-00014
    Event Type
    Injury
    Date Received
    April 22, 2018
    Date of Event
    September 18, 2017
    Report Date
    June 8, 2018
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQE
    PMA / PMN Number
    K983593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) GRANTED ON THE 12 JANUARY 2018: K171625. THE DEVICE WAS NOT RETURNED FOR EVALUATION. A LOT NUMBER WAS NOT PROVIDED FOR THIS COMPLAINT, THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED. FURTHER INFORMATION WAS REQUESTED FROM THE HEALTHCARE FACILITY TO DETERMINE HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE EVENT. THREE ATTEMPTS WERE MADE TO ACQUIRE THIS INFORMATION, BUT A RESPONSE WAS NOT RECEIVED. THERE ARE A NUMBER OF PROCESSES AND CHECKS TO ENSURE THAT ALL PRODUCT IS ADEQUATELY STERILIZED, INSPECTED AND RELEASED PRIOR TO SHIPMENT. THE DEVICE IFU STATES: "INTENDED FOR ONE TIME USE ONLY. THIS IS A STERILE DEVICE AND SHOULD BE STORED AT ROOM TEMPERATURE AWAY FROM DIRECT SUNLIGHT. IF THE PRODUCT PACKAGE IS OPEN OR DAMAGED WHEN RECEIVED, DO NOT USE THIS DEVICE. THE SHELF LIFE OF THE PRODUCT IS 3 YEARS FROM THE DATE OF MANUFACTURE." "INFECTION MAY BE INTRODUCED VIA NEEDLE PUNCTURE AND RESULT IN URINARY TRACT INFECTION (UTI), PELVIC INFLAMMATORY DISEASE (PID), UTERINE INFECTION OR CYSTITIS." "CAREFULLY REMOVE THE NEEDLE FROM THE PACKAGING MAINTAINING THE STERILITY OF THE PRODUCT.THE STERILE NEEDLE SHOULD BE INSPECTED FOR TIP SHARPNESS AND KINKING OF ANY SUPPLIED TUBING." DUE TO THE LIMITED INFORMATION RECEIVED, IT IS DIFFICULT TO DETERMINE A DEFINITIVE ROOT CAUSE. IT IS POSSIBLE THAT ONE OR MORE OF THE FOLLOWING FACTORS MAY HAVE CONTRIBUTED TO THE COMPLAINT: CHANGE IN PROCEDURAL LOCATION/ENVIRONMENT, INEXPERIENCED OPERATOR, INFECTION CONTROL POLICY NOT ADHERED TO, DAMAGED PACKAGING AFTER SHIPMENT CAUSING CONTAMINATION IN DEVICE, IMPROPER STORAGE CONDITIONS CAUSING CONTAMINATION OF DEVICES, OTHER FACTORS RELATED TO DEVICE HANDLING OR STORAGE AFTER SHIPMENT.

    Description of Event or Problem · 0

    THE PATIENT DEVELOPED AN INFECTION (BILATERAL TUBAL OVARIAN ABSCESS) AFTER HAVING AN OVUM ASPIRATION (EGG RETRIEVAL) PERFORMED.

    Additional Manufacturer Narrative · 1

    PMA/510(K) GRANTED ON THE (B)(6) 2018: K171625. PMA/510(K) GRANTED ON THE (B)(6) 2018: K171625.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFECTION (BILATERAL TUBAL OVARIAN ABSCESS) AFTER HAVING AN OVUM ASPIRATION (EGG RETRIEVAL) PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292530 OVUM ASPIRATION NEEDLE SINGLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1