BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING HEMOSTATIC VALVE

    MDR report key: 855828 · Received February 16, 2007

    Report

    Report Number
    2024168-2007-00062
    Event Type
    Malfunction
    Date Received
    February 16, 2007
    Report Date
    December 28, 2006
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    DQO
    Removal / Correction Number
    Z-0390-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER UNITS ARE INDICATED IN THE EVENT DESCRIPTION AND IN AND ARE BEING REPORTED UNDER THE SAME MFR REPORT NUMBER. EVAL SUMMARY: QUALITY ASSURANCE REVEALED THAT THERE WERE 53 UNUSED RHV'S RETURNED. THERE WAS NO BLOOD OR CONTRAST VISIBLE ON ANY OF THE PRODUCTS. THERE WERE TWO POUCHES THAT WERE STILL COMPLETELY SEALED. THERE WERE 30 OF THE POUCHES THAT WERE EITHER COMPLETELY OR PARTIALLY UNSEALED AND THE RHV'S HAD FALLEN OUT OF THE POUCHES AND WERE AT THE BOTTOM OF THE BAG THE RHV'S WERE RETURNED IN. TWENTY TWO OF THE 30 POUCHES HAD A SMALL AMOUNT OF WHITE RESIDUE ON THE PLASTIC PORTION OF THE POUCH. THERE WERE 8 WHERE THE PLASTIC PORTION OF THE POUCH WAS CLEAR. THERE WAS EVIDENCE THAT THE POUCH HAD BEEN PUT THROUGH A BAR SEALER. THERE WERE 21 OF THE POUCHES THAT WERE PARTIALLY UNSEALED BUT THE RHV'S WERE STILL INSIDE THE POUCHES. FIFTEEN OF THE POUCHES HAD WHITE RESIDUE ON THE PLASTIC PORTION OF THE POUCH. THE PLASTIC PORTION OF SIX OF THE POUCHES WAS CLEAR. PRODUCT PERFORMANCE ENGINEERING HAS REVIEWED THE CASE DESCRIPTION AND THE ANALYSIS OF THE 53 DEVICES WITH LOT #6090851. THE ANALYSIS WAS ABLE TO CONFIRM THE CASE DESCRIPTION AS THE MANUFACTURER SEALS WERE OPENED AT LEAST ON 51 OF THE RETURNED PACKAGES. AN INCOMPLETE SEAL BAND WAS OBSERVED ON THE CLEAR SIDES OF THE RETURNED PACKAGES AS THERE WAS MINIMAL/NON-CONTINUOUS CLOUDINESS NOTED WHERE THE SEALING OCCURRED. THERE WERE 2 PACKAGES THAT WERE RETURNED SEALED. NO ATTEMPT WAS MADE TO OPEN THE PACKAGES AS ANALYSIS OF THE 51 PACKAGES CONFIRMED THE CASE DESCRIPTION. IT APPEARS THAT A MANUFACTURING ANOMALY OCCURRED DURING THE SEALING PROCESS OF THE PACKAGES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 53 RHV'S, AND THAT DURING UNPACKAGING, IT WAS NOTED THAT THE PACKAGING SEAL WAS PARTIALLY OPENED. NO ADD'L EVENT OR PT INFO IS AVAILABLE. THIS IS BEING UPGRADED TO MDR REPORTABLE BECAUSE THERE WAS A MALFUNCTION, UNSEALED POUCH, THAT LEAD THE COMPANY TO UNDERGO A CORRECTION AND REMOVAL ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING HEMOSTATIC VALVE 74 DTLII, DYE, DXT, HAP, 76EKX DQO GUIDANT VASCULAR INTERVENTION NA 6090851

    Patients

    Seq Age Sex Outcome Treatment
    1 YR RHV-PART#23242, LOT#6090851(FIFTY-TWO(52) UNITS| SAME PART/LOT#)