BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVUM ASPIRATION NEEDLE SINGLE LUMEN

    MDR report key: 19218790 · Received May 1, 2024

    Report

    Report Number
    9680654-2024-00045
    Event Type
    Injury
    Date Received
    May 1, 2024
    Report Date
    July 16, 2024
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MQE
    UDI-DI
    00827002327412
    PMA / PMN Number
    K983593
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    USED NEEDLE LIKELY DISCARDED. 25 UNUSED DEVICES EXPECTED TO BE RETURNED FOR EVALUATION. TWO SIMILAR EVENTS FROM THE SAME CUSTOMER WERE REPORTED AT THE SAME TIME: (B)(4): HEMOPERITONEUM AFTER OPU PROCEDURE - LOT NUMBER A1138519. (B)(4): HEMOPERITONEUM AFTER OPU PROCEDURE - LOT NUMBER A1084590.

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE USED COMPLAINT DEVICE RELATING TO THIS EVENT WAS NOT RETURNED FOR EVALUATION, 26 UNUSED NEEDLES FROM THE SAME LOT NUMBER WERE RETURNED FOR EVALUATION. THE DEVICES WERE SENT FOR FURTHER EVALUATION BY THE SUBJECT MATTER EXPERT. THE THOROUGH ASSESSMENT CONCLUDED THAT ALL RETURNED DEVICES WERE WITHIN SPECIFICATION AND IN EXCELLENT CONDITION WITH NO SIGNS OF ANY PHYSICAL DAMAGE WHICH WOULD AFFECT THE SHARPNESS OF THE NEEDLES. NO IMAGING WAS RECEIVED TO ASSIST THE INVESTIGATION. REVIEW OF DEVICE HISTORY RECORD (DHR) FOUND THE WORK ORDER FOR LOT A1084590 AND THE RELATED ROOM STOCK WORK ORDERS APPEARED COMPLETE, AND THE QUALITY CONTROL INSPECTION WAS VERIFIED TO ENSURE THAT THE DEVICES PASSED INSPECTION. SOME NON-CONFORMING ROOM STOCK DEVICES WERE REJECTED DUE TO COMPONENT OUT OF SPECIFICATION OR DUE TO DUST AND DEBRIS. THERE IS NO EVIDENCE THAT A DEVICE NON-CONFORMANCE OR DEFICIENCY CONTRIBUTED TO THE REPORTED EVENT. THERE WERE NO TEMPORARY DEVIATIONS IN PLACE AT THE TIME OF MANUFACTURE. REVIEW OF SPECIFICATIONS FOUND THAT THERE ARE A NUMBER OF PROCESSES AND CHECKS IN PLACE WHICH WOULD IDENTIFY A BLUNT OR DAMAGED NEEDLE PRIOR TO SHIPMENT. CLINICAL EVALUATION REPORT FOR OVUM PICK-UP NEEDLES AND SETS ADDRESSES THE FOLLOWING: - HEMORRHAGE/BLEEDING IS WELL-KNOWN AND DESCRIBED IN THE LITERATURE AS A POSSIBLE ADVERSE EVENT OCCURRING FROM THE USE OF ANY OVUM PICK-UP NEEDLE DURING THE OOCYTE COLLECTION PROCEDURE. - IN CONCLUSION, THE COOK OVUM PICK-UP NEEDLES AND SETS ARE CONSIDERED TO BE SAFE AND EFFECTIVE AND TO BE IN ACCORDANCE WITH THE STATE-OF-THE-ART FOR THEIR INTENDED USE. BASED ON THE AVAILABLE INFORMATION AND INSPECTION OF THE RETURNED PRODUCT, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE POTENTIAL ROOT CAUSES ARE: - PATIENT RELATED FACTORS. - PROCEDURAL COMPLICATIONS.

    Description of Event or Problem · 0

    HEMOPERITONEUM AFTER PROCEDURE RETRIEVAL PICKUP OOCYTE.

    Description of Event or Problem · 0

    HEMOPERITONEUM AFTER PROCEDURE RETRIEVAL PICKUP OOCYTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148450 OVUM ASPIRATION NEEDLE SINGLE LUMEN MQE NEEDLE, ASSISTED REPRODUCTION - OVUM PICK-UP ASPIRATION NEEDLES MQE WILLIAM A. COOK AUSTRALIA, PTY LTD A1084590 00827002327412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female