BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPECT

    MDR report key: 2190446 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02519
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    ODG
    PMA / PMN Number
    K100712
    Removal / Correction Number
    Z-3215-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. VISUAL INSPECTION FOUND THAT THE OUTSIDE CARTON LABEL IDENTIFIED THE CONTENTS TO BE A 22GA. EXPECT EUS ASPIRATION NEEDLE DEVICE, BUT THE INNER CONTENTS OF THE PACKAGE CONTAINED A 25GA. EXPECT EUS ASPIRATION NEEDLE DEVICE AND POUCH. THE MOST PROBABLE ROOT CAUSE IS A SUPPLIER LABELING ISSUE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY THIS MANUFACTURER, HOWEVER, THE INVESTIGATION HAS NOT YET BEEN PERFORMED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF TWO DEVICES. REFER TO ASSOCIATED MFR REPORT #3005099803-2011-02520 FOR A DESCRIPTION OF THE OTHER DEVICE. THIS REPORT IS FOR THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT EUS ASPIRATION NEEDLE DEVICE WAS INTENDED FOR USE DURING A EUS PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE OPENING THE OUTER PACKAGING FOR THE EXPECT EUS ASPIRATION NEEDLE, THE OUTER PACKAGING WAS LABELED AS A 22 GA. EXPECT EUS ASPIRATION NEEDLE. HOWEVER, THE STERILE POUCH CONTAINING THE DEVICE WAS FOUND TO READ THAT A 25 GA. NEEDLE WAS IN THE PACKAGE. THE HANDLE ON THE NEEDLE READ 25G AS WELL. THE DEVICE WAS REMOVED FROM SERVICE, AND WAS NEVER USED IN THE PATIENT. A SECOND EXPECT EUS ASPIRATION NEEDLE WAS FOUND TO HAVE THE SAME ISSUE, AND WAS REMOVED FROM SERVICE, AND WAS NEVER USED IN THE PATIENT. A THIRD EXPECT EUS ASPIRATION NEEDLE WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 1

    NOTE: THIS MFR REPORT PERTAINS TO ONE OF TWO DEVICES. REFER TO ASSOCIATED MFR REPORT #3005099803-2011-02520 FOR A DESCRIPTION OF THE OTHER DEVICE. THIS REPORT IS FOR THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT EUS ASPIRATION NEEDLE DEVICE WAS INTENDED FOR USE DURING A EUS PROCEDURE. ACCORDING TO THE COMPLAINANT, WHILE OPENING THE OUTER PACKAGING FOR THE EXPECT EUS ASPIRATION NEEDLE, THE OUTER PACKAGING WAS LABELED AS A 22 GA. EXPECT EUS ASPIRATION NEEDLE. HOWEVER, THE STERILE POUCH CONTAINING THE DEVICE WAS FOUND TO READ THAT A 25 GA. NEEDLE WAS IN THE PACKAGE. THE HANDLE ON THE NEEDLE READ 25G AS WELL. THE DEVICE WAS REMOVED FROM SERVICE, AND WAS NEVER USED IN THE PATIENT. A SECOND EXPECT EUS ASPIRATION NEEDLE WAS FOUND TO HAVE THE SAME ISSUE, AND WAS REMOVED FROM SERVICE, AND WAS NEVER USED IN THE PATIENT. A THIRD EXPECT EUS ASPIRATION NEEDLE WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPECT KIT, NEEDLE, BIOPSY ODG BOSTON SCIENTIFIC - MARLBOROUGH M00550020 13615651C1

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR