BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBC SUCTION WAND

    MDR report key: 2305082 · Received October 19, 2011

    Report

    Report Number
    1645362-2011-00001
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    September 30, 2011
    Report Date
    August 12, 2015
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORP
    Product Code
    DTS
    Removal / Correction Number
    Z-0273-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    IBC SUCTION WAND PART # 1990S WAS MANUFACTURED IN APRIL OF 2011, LOT NUMBER 041811-2065. A TOTAL OF (B)(4) WERE FINISHED AND PLACED INTO INVENTORY. IN (B)(6) 2011 TERUMO CORP ORDERED (B)(4) AND THEY SHIPPED. IN (B)(4) TERUMO RETURNED THESE TO IBC AND ASKED US TO BOX THESE (B)(4) INSIDE (B)(4). THIS WAS DONE AND THEY WERE SHIPPED BACK TO TERUMO. TERUMO THEN SHIPPED THESE TO VARIOUS CUSTOMERS AND WE RECEIVED THE CALL FROM ONE OF THESE CUSTOMERS ON (B)(4) 2011 STATING THAT THE POUCH SEALS WERE BREACHED ON (B)(4) POUCHES. THIS IS WHAT INITIATED THIS RECALL. TERUMO PROVIDED THE LIST OF ALL CUSTOMERS THEY SHIPPED TO AND THEY RETURNED (B)(4) FROM THEIR INVENTORY UNUSED. THE BALANCE OF (B)(4) EACH WENT TO HOSPITALS AND THEY HAVE ALL BEEN CONTACTED WITH RETURN INSTRUCTIONS. THE (B)(4) DISTRICT OFFICE OF THE FDA WAS NOTIFIED OF THIS ON (B)(4) 2011. AN EVALUATION OF DEVICES FROM THE SAME LOT IS UNDERWAY. WHEN THIS STEP IS COMPLETE WE WILL THEN START EVALUATING PRODUCT RETURNED AS A RESULT OF THE RECALL. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ALL EVALUATIONS ARE COMPLETED.

    Description of Event or Problem · 1

    PACKAGING MALFUNCTION - CUSTOMER REPORTED ((B)(6) HOSPITAL) REPORTED THAT THEY RECEIVED 10 EACH STERILE SUCTION WANDS AND 5 HAD THE STERILE SEAL BREACHED. NO USE WITH PTS HAS BEEN REPORTED AT THIS TIME BY ANY RECIPIENTS OF THESE SUCKERS HOWEVER INADVERTENT USE MAY HAVE OCCURRED. A RECALL WAS INITIATED ON 10/05/2011. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBC SUCTION WAND SUCKER DTS INTERNATIONAL BIOPHYSICS CORP 1990S 041811-2065

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other AS OF TODAY (10/19/2011) WE HAVE NO REPORT THAT | THESE WERE USED ON PTS. | THESE WERE USED ON PTS.| AS OF TODAY ((B)(4) 2011) WE HAVE NO REPORT THAT