BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE BIOPSY NEEDLES

    MDR report key: 5784229 · Received July 11, 2016

    Report

    Report Number
    2183456-2016-00006
    Event Type
    Malfunction
    Date Received
    July 11, 2016
    Date of Event
    March 30, 2016
    Report Date
    July 8, 2016
    Manufacturer
    AD-TECH MEDICAL INSTRUMENT CORP.
    Product Code
    HAW
    PMA / PMN Number
    K924348
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT INVESTIGATION IS CURRENTLY ONGOING. AS IT WAS STATED IN THE DESCRIPTION SECTION THAT THE CLINICAL CONSEQUENCES FOR THIS ISSUE RESULTED "IN A MORE IMPORTANT BLEEDING FROM THE BIOPSY SITE.", AD-TECH CONTACTED THE DISTRIBUTOR FOR ADDITIONAL INFORMATION IN REGARDS TO PATIENT IMPACT. AD-TECH IS CURRENTLY WAITING FOR A RESPONSE FROM THE DISTRIBUTOR. A SECOND FAILURE OF SIMILAR NATURE WAS ALSO MENTIONED IN THIS VIGILANCE REPORT FOR A BIOPSY NEEDLE FROM LOT 208140580. A SEPARATE MDR WAS FILED FOR THIS ISSUE UNDER 2183456-2016-00005.

    Description of Event or Problem · 1

    ON JUNE 7, 2016, AD-TECH MEDICAL INSTRUMENT CORPORATION RECEIVED AN EMAIL FROM THE REGULATORY BODY IN (B)(6) REQUESTING ADDITIONAL INFORMATION ON A VIGILANCE REPORT THAT HAD BEEN REPORTED BY A (B)(6) CUSTOMER. IT WAS FOUND THAT "WHEN PERFORMING A BIOPSY, THE INNER CANNULA GETS STUCK AND THE CUT IS NOT GOOD. THE INCIDENT HAPPENED TWICE WITH 2 NEEDLES COMING FROM THE SAME BATCH/LOT." AD-TECH CONTACTED THE DISTRIBUTOR FOR THIS CUSTOMER FOR ADDITIONAL INFORMATION AND OBTAIN A COPY OF THE VIGILANCE REPORT. IT WAS STATED THAT THEY WERE WORKING WITH THE CUSTOMER TO RESOLVE THIS ISSUE. ACCORDING TO THE REPORT, THE CUSTOMER STATED THE CLINICAL CONSEQUENCES FOR THIS ISSUE RESULTED "IN A MORE IMPORTANT BLEEDING FROM THE BIOPSY SITE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435948 DISPOSABLE BIOPSY NEEDLES DISPOABLE BIOPSY NEEDLES HAW AD-TECH MEDICAL INSTRUMENT CORP. 208140580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other