BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AORTIC PUNCH

    MDR report key: 4912727 · Received July 11, 2015

    Report

    Report Number
    1645362-2015-00001
    Event Type
    Malfunction
    Date Received
    July 11, 2015
    Date of Event
    June 11, 2015
    Report Date
    July 10, 2015
    Manufacturer
    INTERNATIONAL BIOPHYSICS CORP.
    Product Code
    LRY
    Removal / Correction Number
    1645362-11242015-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS A F/U TO THE INITIAL MDR 1645362-2015-00001. THE PRODUCT RECALL HAS BEEN COMPLETED (1645362-11/24/2015-002-R). AT THIS TIME, IBC HAS NOT RECEIVED ANY ADVERSE EVENT REPORTS RELATED TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    IBC AORTIC PUNCH CATALOG NO: CVAPL44 WAS MANUFACTURED IN 02/2015 AND ASSIGNED LOT NO: 022515-3384. A TOTAL OF (B)(4) WERE COMPLETED AND PLACED INTO INVENTORY. THE ENTIRE LOT ((B)(4)) WAS SHIPPED TO (B)(4). ON (B)(6) 2015, IBC WAS NOTIFIED BY (B)(4) THAT A CUSTOMER HAD DISCOVERED SEVERAL POUCHES FROM THIS LOT WHICH WERE OPENED ALONG THE IBC HEAT SEAL. (B)(4) RETURNED A TOTAL OF (B)(4) DEVICES FROM LOT 022515-3384, FROM WHICH IT WAS CONFIRMED THAT (B)(4) OF THE DEVICES WERE AT LEAST PARTIALLY BREACHED ALONG THE IBC-FORMED HEAT SEAL. EVAL AND INVESTIGATION OF THIS FAILURE IS STILL UNDERWAY. IBC RECEIVED BACK DEVICES FROM (B)(4) ON 06/24/2015 FOR EVAL. IBC IS IN THE PROCESS OF INITIATING A RECALL FOR THIS ISSUE. A F/U REPORT WILL BE SUBMITTED WHEN ALL EVALUATIONS ARE COMPLETE.

    Description of Event or Problem · 1

    PACKAGING MALFUNCTION: CUSTOMER REPORTED ((B)(4)) THAT THEY CHECKED STOCK OF CVAPL44 LOT 022515-3384 AND FOUND SEVERAL UNSTERILE DEVICES. THE HEAT SEAL AT THE TOP WAS FOUND TO BE OPEN AFTER SHIPPING. IBC HAS NOT RECEIVED ANY ADVERSE EVENT REPORTS RELATED TO THIS ISSUE. IBC IS INITIATING A RECALL RELATED TO THIS ISSUE. AS OF TODAY ((B)(6) 2015), WE HAVE NO REPORT THAT THESE WERE USED ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451344 AORTIC PUNCH AORTIC PUNCH LRY INTERNATIONAL BIOPHYSICS CORP. CVAPL44 022515-3384

    Patients

    Seq Age Sex Outcome Treatment
    1