BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PROBETEC ET CT/GC COLLECTION KIT FOR ENDO

    MDR report key: 961660 · Received December 6, 2007

    Report

    Report Number
    1119779-2007-00008
    Event Type
    Other
    Date Received
    December 6, 2007
    Date of Event
    November 9, 2007
    Report Date
    December 6, 2007
    Manufacturer
    PURITAN MEDICAL PRODUCTS CO LLC
    Product Code
    LIO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SWAB TIP WAS RETURNED FOR EVALUATION WITHOUT THE SHAFT. THE TIP WAS INTACT SUGGESTING NO FORCE AND A DEPARTING FROM THE SHAFT. SINCE EXAMINATION OF THE SHAFT CANNOT BE DONE, THE THEORY IS THE GLUE WAS NOT SUFFICIENT TO RETAIN THE TIP DURING COLLECTION. RECORDS FOR THIS LOT OF MATERIAL WERE EXAMINED AND NO ANOMALIES WERE NOTED DURING THE PACKAGING OF THE PRODUCT OR AT INCOMING INSPECTION FOR THE LOT OF SWAB MATERIAL USED TO MANUFACTURE THIS LOT OF FINISHED PRODUCT. A 3 YEAR BATCH HISTORY REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE NOTED FOR THE SWAB. CONTROL POINTS WERE VERIFIED WITH THE SWAB VENDOR AND DETERMINED THAT QUALITY TESTING MET PRODUCT SPECIFICATIONS. BASED ON INVESTIGATION RESULTS AND TRENDING DATA, THIS APPEARS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    DURING SAMPLE COLLECTION FROM THE CERVIX, THE FOAM TIP OF THE SWAB CAME OFF INSIDE THE PT. THE CLINIC COLLECTING THE SAMPLE WAS UNABLE TO RETRIEVE THE SWAB TIP AND HAD TO SEND THE PT TO A GYN FOR REMOVAL. THE GYN PERFORMED AN ENDOMETRIAL BIOPSY AND THE DOCTOR WAS ABLE TO SUCTION OUT THE SWAB TIP THAT WAS LODGED IN THE PT'S VAGINA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PROBETEC ET CT/GC COLLECTION KIT FOR ENDO LIO PURITAN MEDICAL PRODUCTS CO LLC 6313350

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other