BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 8029979 · Received November 1, 2018

    Report

    Report Number
    9610048-2018-00179
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 12, 2018
    Report Date
    November 9, 2018
    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

    INVESTIGATION SUMMARY: ON 10/31/2018, (B)(4) UNUSED UNITS IN SLIGHTLY OPENED PACKAGE FROM CATALOG NUMBER: 381112, LOT NUMBER: 6180339 WERE RECEIVED. THE SAMPLES WERE ANALYZED AT BD SANDY WHERE IT WAS CONFIRMED OPENED PACKAGES. THIS IS THE SECOND COMPLAINT FOR PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE FOR LOT: 6180339, PRODUCT CODE: 381112. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR FINAL PRODUCT CATALOG#: 381112, LOT: 6180339 MANUFACTURED FROM 30-JUN-16 TO 01-JUL-16 IN MULTIVAC R530-2 PACKAGE MACHINE. THIS LOT WAS REVIEWED REGARDING THE FOLLOWING TESTS: ADHESIVE TRANSFER TEST, WHICH IS EVIDENCE THROUGH MARK OF THE SEALING FILM, THE ADHESIVENESS OF THE PAPER WAS TRANSFERRED TO THE BOTTOM WEB, ASSURING THE SEALING OF THE PRODUCT; PACKAGING LEAKAGE TEST, WHICH IS A TEST THAT CHALLENGES THE INTEGRITY OF THE SEALING, AS THE HOLES, SEALING CHANNELS OR ANY OTHER BREACH OF THE SEALING THAT COULD COMPROMISE THE STERILIZATION OF THE PRODUCT; WIDTH AND SEALING TEST, WHICH EVALUATES THE PARAMETER ACCORDING INTERNALLY SPECIFIED THAT THE WIDTH OF THE SEAL SHOULD BE GREATER THAN 3.2 MM ALSO WERE ALL WITHIN SPECIFICATIONS. ALL PARAMETERS OF THE SEALING MACHINE WERE WITHIN THAT SPECIFIED FOR THE CLAIMED LOT. BASED ON THIS ANALYSIS, NO RECORDS WERE FOUND THAT COULD LEAD TO THE INCIDENT IN QUESTION. QN/ NCMR REVIEW: THERE ARE NO QUALITY NOTIFICATION (QN) OR NONCONFORMITY REPORT OF "PACKAGE SEAL INTEGRITY POOR/QUESTIONABLE¿ OR ANYTHING THAT COULD LEAD TO BE RELATED TO THIS COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER COMPLAINT FOR THE CLAIMED DEFECT. ALTHOUGH THERE WERE NO RECORDS OF FAILURE/ INTEGRITY OF THE SEAL IN THE BATCH HISTORY ANALYSIS AND IN THE RECORDS OF NON-CONFORMITY OR QUALITY NOTIFICATION FOR THE CLAIMED BATCH, THE COMPLAINT WAS CONFIRMED BY ANALYZING THE PHOTOS OF THE CUSTOMER CONTAINING THE DEFECT CLAIMED. IT SHOULD BE NOTED THAT THE PHOTOS IN ATTACHMENT DEMONSTRATE THE SEALING MARK ON THE FILM, WHICH SHOWS THAT SEALING OCCURRED NORMALLY DURING THE SEALING PROCESS. 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 OLIVER TOLAS (SUPPLIER OF PAPER USED IN THE CLAIMED LOTS). HOWEVER, BESIDES ALTHOUGH THE PHOTOS CONFIRMED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD ANGIOCATH¿ IV CATHETER, THE PACKAGE WAS OPENED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, 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 PACKAGE WAS OPENED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868226 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 6180339 30382903811121

    Patients

    Seq Age Sex Outcome Treatment
    1 Other