BEUDAMED
    FDA Adverse Event Summary report: N

    CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS

    MDR report key: 5429420 · Received February 10, 2016

    Report

    Report Number
    1718850-2016-00028
    Date Received
    February 10, 2016
    Date of Event
    January 18, 2016
    Report Date
    January 18, 2016
    Manufacturer
    SORIN GROUP USA
    Product Code
    DTS
    PMA / PMN Number
    K982891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TIP OF THE RIGID TIP SUCTION WAND CANNULA WAS DETACHED AND LEFT BEHIND IN THE LEFT ATRIUM DURING THE PROCEDURE. THE TIP WAS REMOVED FROM THE PATIENT AS SOON AS IT WAS DISCOVERED THAT THE TIP WAS DETACHED. THERE WAS NO REPORT OF PATIENT INJURY. TWO SUCTION SUMP CANNULA AND ONE SUCTION SUMP TIP WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE TWO CANNULA CONFIRMED THAT THE TIP WAS MISSING FROM BOTH UNITS. THERE WAS STRONG EVIDENCE OF ADHESIVE PRESENT ON BOTH RETURNED UNITS. VISUAL INSPECTION OF THE RETURNED TIP FOUND THAT IT APPEARED TO HAVE BEEN TORN OFF OF THE REST OF THE TUBING. THIRTY RIGID TIP SUCTION WAND CANNULAE WERE PULLED FROM THREE DIFFERENT LOTS FROM INVENTORY FOR PULL TESTING. ALL UNITS SUSTAINED PULL FORCES HIGHER THAN THE SPECIFICATIONS FOR THE PRODUCT (10LBF) PRIOR TO FAILURE OF THE DEVICE. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER DOCUMENTED A PULL FORCE OF 21.41LBF DURING IN-PROCESS TESTING. THE DEVICE WAS DETERMINED TO MEET ALL APPLICABLE SPECIFICATIONS AND A ROOT CAUSE FOR THE ISSUE COULD NOT BE DETERMINED. ALTHOUGH NO DEFECTS WERE IDENTIFIED, SEVERAL UPDATES WERE MADE TO THE DOCUMENTATION (FINAL ASSEMBLY INSTRUCTIONS AND SHOP ORDER DETAIL) FOR THIS PRODUCT TO ENSURE ADEQUATE AND CONSISTENT ADHESION APPLICATION.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED. SORIN GROUP RECEIVED A REPORT THAT THE TIP OF THE RIGID TIP SUCTION WAND CANNULA WAS DETACHED AND LEFT BEHIND IN THE LEFT ATRIUM DURING THE PROCEDURE. THE TIP WAS REMOVED FROM THE PATIENT AS SOON AS IT WAS DISCOVERED THAT THE TIP WAS DETACHED. THERE WAS NO REPORT OF PATIENT INJURY. THE DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP USA FOR FURTHER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE TIP OF THE RIGID TIP SUCTION WAND CANNULA WAS DETACHED AND LEFT BEHIND IN THE LEFT ATRIUM DURING THE PROCEDURE. THE TIP WAS REMOVED FROM THE PATIENT AS SOON AS IT WAS DISCOVERED THAT THE TIP WAS DETACHED. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85435 CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS DTS SORIN GROUP USA SU-29602 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1