BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 20875578 · Received December 8, 2024

    Report

    Report Number
    9680654-2024-00077
    Event Type
    Malfunction
    Date Received
    December 8, 2024
    Date of Event
    November 25, 2024
    Report Date
    December 9, 2024
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQE
    UDI-DI
    00827002304604
    PMA / PMN Number
    K983593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    3 X USED AND 2 X UNUSED NEEDLES WERE REPORTED.

    Additional Manufacturer Narrative · 0

    3 X USED AND 2 X UNUSED NEEDLES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER DESPITE MULTIPLE REQUESTS, NO ADDITIONAL INFORMATION WAS RECEIVED. A DEVICE EVALUATION COULD NOT BE PERFORMED AS NEITHER THE DEVICE NOR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER A1167304 AND RELATED COMPONENT LOT NUMBERS WERE REVIEWED AND FOUND TO CONTAIN NO RELATED NON-CONFORMANCES RECORDED. THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMED THAT THE REPORTED FAILURE HAS NOT PREVIOUSLY BEEN REPORTED FOR THIS MANUFACTURING LOT A1167304. REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT BASED ON THE CURRENT DOCUMENTATION, SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO LIKELY IDENTIFY FAULTY PRODUCT PRIOR TO DISTRIBUTION. DUE TO THE LACK OF INFORMATION SUPPLIED AND RECEIVING NO RESPONSE TO THE ADDITIONAL QUESTIONS SENT TO THE CUSTOMER, (INCLUDING DETAILS ABOUT THE EQUIPMENT USED WITH THE NEEDLES, THE NEEDLES THEMSELVES, PATIENT CONDITIONS, AND WHETHER ANY INTERVENTIONS WERE REQUIRED) A DEFINITIVE ROOT CAUSE TO EXPLAIN THE DIFFICULTY IN VISUALISING THE NEEDLE EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. NO HARM TO THE PATIENT WAS REPORTED, APART FROM A POTENTIAL DELAY IN COMPLETION OF THE OVUM PICK UP (OPU) PROCEDURE, AND NUISANCE TO THE SURGEON AND THEATRE STAFF. THERE ARE SEVERAL PROCESSES AND CHECKS IN PLACE AT THE MANUFACTURING FACILITY TO ENSURE THAT EACH NEEDLE IS ADEQUATELY ECHO-TIPPED TO FACILITATE VISUALISATION. THEREFORE, IT IS POSSIBLE THAT THE DIFFICULTY OBSERVED BY THE CUSTOMER WAS RELATED TO THE ULTRASOUND EQUIPMENT AND ITS SETTINGS, OR AN ISSUE WITH THE NEEDLE GUIDE, AND MOST LIKELY FACTORS OUTSIDE OF THE CONTROL OF THE MANUFACTURER. SHOULD ADDITIONAL INFORMATION BE RECEIVED AT ANY TIME IN THE FUTURE, AN ADDITIONAL REPORT MAY BE SUBMITTED.

    Description of Event or Problem · 0

    IN 5 UNITS OF THE NEEDLES, THE DIAMETER OF THE TIP OF THE NEEDLE LOOKS SMALLER AND THEY CANNOT SEE PROPERLY UNDER ULTRASOUND-ECO TIP IS NOT VISIBLE CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333375 OVUM ASPIRATION NEEDLE SINGLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD A1167304 00827002304604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female