BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPTY DISPOSIBLE NEEDLE

    MDR report key: 5007179 · Received July 28, 2015

    Report

    Report Number
    2020394-2015-01175
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Report Date
    February 5, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K922939
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER CLINICAL REVIEW OF THIS EVENT WITH BARD'S MEDICAL DEPARTMENT, THIS EVENT WAS REASSESSED AND DETERMINED TO BE MDR REPORTABLE AS A MALFUNCTION PURSUANT TO 21CFR PART 803. A MANUFACTURING REVIEW WAS CONDUCTED AND THE REPORTED LOT MET ALL RELEASE CRITERIA. THE INVESTIGATION IS INCONCLUSIVE, AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. AN INVENTORY ASSESSMENT WAS PERFORMED AND IT INDICATED THAT NO PRODUCT WAS AVAILABLE IN INVENTORY FOR ASSESSMENT FOR THIS LOT NUMBER. THE MANUFACTURING PRODUCTION SCHEDULE WAS REVIEWED AND THE PREVIOUS THREE WORK ORDERS DO NOT MATCH THE DESCRIPTION OF THE SUSPECTED MIXED PRODUCT. THEREFORE, THE CHANCE THAT THE REPORTED EVENT WAS RELATED TO A PRODUCT MIX-UP AT MANUFACTURING IS HIGHLY UNLIKELY AND IMPROBABLE. FURTHERMORE, A LOT SALES HISTORY REVIEW WAS CONDUCTED AND IT INDICATED THAT PRODUCT CATALOG NUMBER 121810 (18G X 10CM) WAS SHIPPED TO THE FACILITY PRIOR TO 121816 (18G X 16CM), IT IS POSSIBLE THAT THE NEEDLES WERE SWITCHED AT SOME POINT AFTER THEY WERE RECEIVED BY THE FACILITY. HOWEVER, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. THE MONOPTY INSTRUCTIONS FOR USE (IFU) PROVIDES GENERAL INSTRUCTIONS FOR PRIMING, FIRING, SAMPLING AND RETRIEVAL OF SAMPLES FROM THE DEVICE. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR A BIOPSY PROCEDURE, THE PACKAGING WAS OPENED AND THE WRONG SIZE NEEDLE WAS IN THE PACKAGE. THE NEEDLE SHOULD HAVE BEEN AN 18X16 AND IT WAS AN 18X10. ANOTHER 18X16 NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491202 MONOPTY DISPOSIBLE NEEDLE KNW BARD PERIPHERAL VASCULAR, INC. REWF1819

    Patients

    Seq Age Sex Outcome Treatment
    1