BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOOD PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET

    MDR report key: 2860812 · Received October 29, 2012

    Report

    Report Number
    1820334-2012-00486
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Report Date
    October 2, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED TO ASSIST IN THIS INVESTIGATION. PER QUALITY CONTROL, THE NEEDLE IS STATISTICALLY SAMPLED TO VERIFY THAT THE CORRECT COLLAR HAS BEEN APPROPRIATELY PLACED, THE SECUREMENT OF THE COLLAR IS VERIFIED AND THE WELDED TIP IS INSPECTED TO ENSURE TIP IS FREE OF BURRS AND NOT BUFFED TO THIN. EACH NEEDLE IS CHECKED TO VERIFY THAT THE LUMEN IS OPEN AND THAT THERE IS NO VISIBLE DAMAGE. PER SPECIFICATION, THE NEEDLE AND CATHETER ARE A MATCHED SET AND THE NEEDLE AND CATHETER ARE STATISTICALLY SAMPLED TO VERIFY THAT THE APPROPRIATE NEEDLE IS USED. EACH NEEDLE IS INSPECTED TO ENSURE SMOOTH TRANSITION BETWEEN THE NEEDLE AND CATHETER. AN IFU IS PROVIDED WITH THIS DEVICE. WITHOUT THE COMPLAINT PRODUCT AN EXAMINATION OF THE SOLDER JOINT CANNOT BE PERFORMED. THE APPEARANCE IN THE PHOTO DOES NOT PROVIDE SUFFICIENT RESOLUTION IF SUFFICIENT SOLDER HAD BEEN USED. REQUESTS TO OBTAIN THE COMPLAINT DEVICE HAVE BEEN UNSUCCESSFUL. IN THE ABSENCE OF ADDITIONAL EVIDENCE, SUCH AS THE COMPLAINT DEVICE, THE ROOT CAUSE IS INCONCLUSIVE. INSUFFICIENT RISK PER QUALITY ENGINEERING RISK ANALYSIS. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE REGISTRAR WAS INSERTING THE PRODUCT AND FELT SHE HIT A RIB, SO SHE ANGLED THE NEEDLE AND TRIED TO GO UNDER THE RIB, BUT SHE FELT IT WAS 'NOT RIGHT'. SHE CONSULTED WITH FELLOW AND IT WAS SUGGESTED TO REMOVE THE DEVICE, AND START AGAIN. ON REMOVAL, IT WAS NOTED THAT THE TIP OF THE NEEDLE WAS SITTING AT THE END OF THE CATHETER AND THAT THE NEEDLE SHAFT WAS NOT ATTACHED TO THE TIP OF THE NEEDLE. COOK SALES REP HAS TAKEN PHOTOS AS SHE WAS NOT ABLE TO TAKE THE PRODUCT DUE TO THE HOSPITAL POLICY OF MANAGEMENT NEEDING TO VIEW ANY COMPLAINT PRODUCT PRIOR TO RELEASING IT TO THE MANUFACTURER COMPANY. THE PATIENT SUFFERED NO ADVERSE EFFECTS AT ALL. THE DOCTORS DECIDED TO INSERT A DIFFERENT PRODUCT ALTOGETHER INSTEAD OF OPENING ANOTHER COOK SET. X-RAY WAS DONE FOLLOWING CHEST TUBE INSERTION WHICH WAS UNEVENTFUL. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WOOD PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET DQO COOK, INC. NA 3319473

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK