BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8401079 · Received March 7, 2019

    Report

    Report Number
    9610048-2019-00128
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Date of Event
    February 15, 2019
    Report Date
    March 22, 2019
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811121
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD WAS ABLE TO VERIFY THE REPORTED ISSUE OF PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE. THE FOUR SAMPLES WERE RECEIVED WITH OPENED PACKAGING. IT SHOULD BE NOTED THAT THE SAMPLES DEMONSTRATED THE SEALING MARK ON THE FILM, WHICH SHOWS THAT SEALING OCCURRED NORMALLY DURING THE SEALING PROCESS. AS A POSSIBLE CAUSE OF THIS DEFECT WOULD BE A FAILURE IN THE ADHESIVENESS OF THE PAPER WITH THE FILM DUE TO THE LACQUER CONTAINED IN THE PAPER FROM THE SUPPLIER. HOWEVER, THE SAMPLE VERIFIED THE OPEN PACKAGE COMPLAINT, IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS DEFECT, DUE TO THE ABSENCE OF NONCONFORMITIES RELATED TO THIS DEFECT AND DUE TO THE LACK OF OBJECTIVE EVIDENCE IN THE DEVICE HISTORY RECORD OF PACKAGING CLAIMED, SUCH AS: THE PACKAGING PARAMETERS ARE WITHIN THE SPECIFICATIONS, THE ADHESIVE TRANSFER MARK ON THE FILM, WHICH PROVES THAT THE PRODUCT HAS BEEN PROPERLY SEALED DURING THE PACKAGING OF THE PRODUCT. SINCE A POSSIBLE CAUSE OF THIS DEFECT WOULD BE A FAILURE IN THE ADHESIVENESS OF THE PAPER WITH THE FILM DUE TO THE LACQUER CONTAINED IN THE PAPER FROM THE SUPPLIER, IT WAS DETERMINED AS ACTION A CHANGE CONTROL WHICH CONTEMPLATES THE EXCHANGE OF THE SUPPLIER OF THE PAPER TO ONE WHICH DOES NOT HAVE LACQUER AS ADHESIVE, SINCE THE ADHESIVENESS OF THE PAPER WILL BE CARRIED OUT IN ANOTHER WAY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER THE SEAL WAS OPEN ON THE PACKAGE. THERE WERE TWO OCCURRENCES.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7150528. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2017-06-09. MEDICAL DEVICE LOT #: 7209785. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2017-08-30. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER THE SEAL WAS OPEN ON THE PACKAGE. THERE WERE TWO OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195222 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. SEE H.10 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other