BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7345222 · Received March 16, 2018

    Report

    Report Number
    9610048-2018-00021
    Event Type
    Malfunction
    Date Received
    March 16, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 22, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER ADDRESS: AV. DR. ARNALDO PRADO CURVELLO, 10-110 PARQUE SANTA TEREZINHA // ROD. BAURU-JAÚ. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: INVESTIGATION COMMENTS: THE ANALYSIS OF THE PHOTOS CONTAINING THE CLAIMED SAMPLE SHOWED THAT THERE WAS ONE UNIT OF INSYTE AUTOGUARD 22G INSIDE THE INSYTE AUTOGUARD 24G PACKAGE. IN ADDITION, EVIDENCE IN THE BATCH HISTORY OF AN INSYTE AUTOGUARD 22G PREVIOUSLY PACKAGED WITH THE INSYTE AUTOGUARD 24G REINFORCES THE SUSPICION THAT A LINE CLEANUP MAY ACTUALLY HAVE OCCURRED. ALTHOUGH HAVING SAMPLES AVAILABLE FOR ANALYSIS, THE CONCLUSION OF THE INVESTIGATIONS OF THIS COMPLAINT DOES NOT REQUIRE THE PRESENCE OF PHYSICAL SAMPLES, DHR REVIEW: THE CLAIMED LOT: 7241892 OF INSYTE-N AUTOGUARD YEL 24GA X 0.56IN PRODUCT WAS PACKED IN MACHINE R530-1 ON 08/31/2017. THE BATCH IN QUESTION WAS ANALYZED FOR THE "INCORRECT PRODUCT INSIDE THE PACKAGE" TEST AMONG OTHER TESTS PERFORMED AND NO RECORDS WERE FOUND THAT COULD LEAD TO THE INCIDENT IN QUESTION. HOWEVER, DURING THIS ANALYSIS IT CAN BE VERIFIED THROUGH FORM DGF053-0 / 13 - CHECK-LIST DE LIBERACAO DAS EMBALADORAS THAT THE LOT PACKED BEFORE THE CLAIMED LOT WAS IN FACT A LOT OF INSYTE AUTOGUARD 22G, WHICH EVIDENCES PRODUCT MIX RESULTING FROM A FAILURE IN THE LINE CLEANING, THAT IS, IN THE EXCHANGE OF ONE BATCH BY THE OTHER IN THE SAME PACKAGING MACHINE. QN/ NCMR REVIEW: NO RECORDS OF QUALITY NOTIFICATION OR REPORTS OF NON-CONFORMITY THAT COULD LEAD TO INCIDENT IN TO THE CLAIMED LOT IN THIS COMPLAINT WERE EVIDENCED. BASED ON THE INVESTIGATIONS CARRIED OUT, THIS COMPLAINT MAY HAVE BEEN CAUSED AS DUE TO A FAILURE OF LINE CLEANING IN THE R530-1 MACHINE BY THE OPERATORS; AS BY THE FACT OF INSYTE AUTOGUARD 22G PART HAS FALLEN BETWEEN THE PROTECTIONS OF THE AUTOMATIC FEEDING MACHINE (AUTOLOADER) AND BECAUSE OF THOUGH ACCESS, IT MAY NOT HAVE BEEN REMOVED DURING THE BATCH EXCHANGE (LINE CLEANING) AND ACCIDENTALLY PACKED TOGETHER WITH THE INSYTE AUTOGUARD 24G LOT CLAIMED, WITHOUT HAVING BEEN NOTICED BY THE OPERATORS OF THE PRODUCT INSPECTION OF THE CONVEYOR BELT AFTER THE SEALING. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED DEFECT WILL CONTINUE TO BE TRACKED AND TRENDED. THE INFORMATION WILL BE CAPTURED IN THE TREND REPORTS AND MONITORED MONTHLY. COLLECTED DATA ARE REGULARLY REVIEWED TO IDENTIFY EMERGING TRENDS. BASED ON THIS, A CAPA IS NOT NEEDED AT THIS TIME. OTHER TAKEN ACTION: THE OPERATORS OF THE PACKAGING AREA WILL BE NOTIFIED OF THE INCIDENT IN QUESTION IN ORDER TO AVOID THIS TYPE OF OCCURRENCE. IN ADDITION, NEW PROTECTIONS FOR INSTALLATION IN THE PACKAGING MACHINE WERE PURCHASED AS OF (B)(6) 2017 (AFTER THE DATE OF PACKAGING OF THE CLAIMED PRODUCT, WHICH WAS 08/31/2017). THESE PROTECTIONS, IN ADDITION TO OTHER PURPOSES, ARE INTENDED TO COVER HARD-TO-REACH AREAS OF THIS MACHINE AND THUS CONTAIN PRODUCTS THAT MAY FALL INTO THOSE AREAS DURING PACKAGING AND COME TO LOOSEN AT A LATER TIME AND MAY GENERATE PRODUCT MIX AS CLAIMED. IT SHOULD BE NOTED THAT THESE PROTECTIONS ARE ALREADY PROPERLY INSTALLED ON THE PACKAGING MACHINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE A BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER WAS FOUND WITH INCORRECT LABELING AS A 22 GAGE CATHETER WAS LABELED IN A 24 GAGE PACKAGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187498 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 7241892

    Patients

    Seq Age Sex Outcome Treatment
    1 Other