BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE DOUBLE LUMEN

    MDR report key: 15136903 · Received July 31, 2022

    Report

    Report Number
    9680654-2022-00012
    Event Type
    Injury
    Date Received
    July 31, 2022
    Report Date
    October 6, 2022
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQE
    UDI-DI
    00827002557970
    PMA / PMN Number
    K983593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE VISUAL INSPECTION AND FUNCTIONAL TEST COULD NOT BE PERFORMED. NO IMAGES WERE PROVIDED FOR EVALUATION. A REVIEW OF DEVICE HISTORY RECORD FOR WORK ORDER NUMBER (B)(4) WAS REVIEWED AND APPEARS COMPLETE AND CORRECT WITH NO EVIDENCE THAT A DEVICE NON-CONFORMANCE OR DEFICIENCY CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF SPECIFICATIONS FOUND THAT A NUMBER OF PROCESSES AND CHECKS IN PLACE DURING MANUFACTURING WHERE ANY BLOCKAGES WOULD MOST LIKELY BE DETECTED. THE SUBJECT MATTER EXPERT MEDICAL AFFAIRS WAS CONSULTED ON THE POTENTIAL ROOT CAUSE. IT WAS REFERENCED ¿THE COMMONEST CAUSE OF EARLY COLLAPSE/FRAGILITY OF THE FOLLICLE IS THAT THE FOLLICLE IS ON THE POINT OF RUPTURING SPONTANEOUSLY, IN RESPONSE TO THE LUTEINIZING HORMONE [LH] TRIGGERING. THIS CAN BE DUE TO INCORRECT TIMING OF THE TRIGGER, OR IDIOSYNCRATIC INDIVIDUAL PATIENT RESPONSE. SUCH UNUSUAL SENSITIVITY COULD MAKE THE PREOVULATORY FOLLICLE UNEXPECTEDLY FRAGILE, AND IT COULD MORE EASILY RUPTURE, WITH CONSEQUENT LOSS OF THE OOCYTE. A SURGEON WHO IS INEXPERIENCED COULD ENTER FOLLICLES WITH THE ASPIRATING PRESSURE NOT YET TURNED ON. IN THIS SITUATION, A TEAR OF THE FOLLICLE COULD ALLOW THE FLUID TO ESCAPE BEFORE THE ASPIRATION STARTS. THAT THE SAME PROBLEM HAPPENED WITH THREE FOLLICLES DOES RAISE THE POSSIBILITY OF A HOOK ON THE TIP OF THE NEEDLE WHICH MAKES A BIGGER HOLE ON ENTRY THAN USUAL; BUT IF THE SUCTION IS HAPPENING, THE OOCYTE IS USUALLY STILL CAPTURED¿. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE IS UNKNOWN. ANY NON-CONFORMANCE WITH A DEVICE WOULD MOST LIKELY BE DETECTED PRIOR TO PATIENT CONTACT DURING THE COMMON CLINICAL PRACTICE OF A PRE-FLUSH WITH MINIMAL RISK TO THE PATIENT. PLEASE NOTE THAT AN UPDATED 510(K) NUMBER HAS BEEN ISSUED FOR THIS DEVICE (SPECIAL 510K 171611).

    Description of Event or Problem · 0

    NEEDLE COLLAPSED 3 FOLLICLES.

    Description of Event or Problem · 0

    NEEDLE COLLAPSED 3 FOLLICLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2922657 OVUM ASPIRATION NEEDLE DOUBLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD G55797 A1092943 00827002557970

    Patients

    Seq Age Sex Outcome Treatment
    1 Female