BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH¿ IV CATHETER

    MDR report key: 7351107 · Received March 19, 2018

    Report

    Report Number
    9610048-2018-00020
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 20, 2018
    Report Date
    March 23, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    30382903811343
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOR THE FOREIGN MATTER IN QUESTION AFTER ANALYSIS AND THE FTIR RESULTS, IT WAS POSSIBLE TO VERIFY THE PRESENCE OF ¿CELOPHANE¿ AND ¿EVA (ETHYLENE VINYL ACETHATE)¿, CONFIRMING THE CUSTOMER'S COMPLAINT. REGARDING THE INTEGRITY OF THE CATHETER TIP, THE DEFECTS CLAIMED FOR THE PRODUCT WERE NOT EVIDENCED. IN ADDITION, NO RECORDS OF RELATED NONCONFORMITIES WERE FOUND THAT COULD LEAD TO THE INCIDENT IN QUESTION. AS PER REQUEST, FTIR ANALYSIS WAS CARRIED OUT ON EACH OF THE TWO TYPES OF FM SEEN ON THE CATHETER. A SMALL PORTION OF EACH OF THE MATERIALS SEEN ON THE CATHETER WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THE WHITE MATERIAL ON THE CATHETER IS MOST LIKELY ETHYLENE VINYL ACETATE AND THE CLEAR STRAND OF MATERIAL ON THE CATHETER IS MOST LIKELY CELLOPHANE AND SILICONE. SAMPLES/ PHOTOS: WE RECEIVED SAMPLES OF THE CLAIMED PRODUCT AND ACCORDING TO THE ANALYSIS, IT WAS POSSIBLE TO CONFIRM THE PRESENCE FOREIGN MATTER ON THE CATHETER. DHR REVIEW: AFTER ANALYSIS OF THE RECLAIMED LOTS OF ASSEMBLED SET: 4357269, 5030022 AND 4300253 USED IN THE FINAL PRODUCT BATCH: 5036034 OF ANGIOCATH 20GA X 116IN, NO EVIDENCED AS TO THE TESTS TO VERIFY THE PRESENCE OF "FOREIGN / NO FOREIGN MATTER" AND NO RECORDS OF THIS DEFECT WERE EVIDENCED. QN/ NCMR REVIEW: THERE ARE NO RECORDS OF QUALITY NOTIFICATION (QN) OR NON-CONFORMANCE REPORT (RNC) OF FOREIGN MATTER, FOR THE LOT INVOLVED IN THIS CLAIM, ACCORDING TO THE HISTORY OF THE LOT ABOVE. INVESTIGATION CONCLUSION: CONFIRMED: FOR THE DEFECT CLAIMED FOREIGN MATTER, BD WAS ABLE TO CONFIRM/ REPRODUCE BOTH FOREIGN MATTER FOUND IN QUESTION. NOT CONFIRMED: FOR THE CLAIMED DEFECT OF CATHETER INTEGRITY, BD CANNOT CONFIRM / REPRODUCE THE INCIDENT IN QUESTION. WITH RESPECT TO THE COMPLAINT OF CELLOPHANE, THROUGH PREVIOUS INVESTIGATIONS IT CAN BE VERIFIED THAT A POSSIBLE DISSEMINATOR OF CELLOPHANE PARTICLES WAS THE FABRIC USED TO CLEAN THE ELEVATORS OF THE ANGIOCATH ASSEMBLY MACHINES, WHICH CAN LEAVE THIS KIND OF RESIDUE. THE WHITE POINT OBSERVED ON THE CATHETER, ACCORDING TO THE FTIR TESTS PERFORMED BY BD USA, RESULTED IN THE SUBSTANCE CALLED "ETHYLENE VINYL ACETATE" WHICH IS THE ADHESIVE SUBSTANCE (LACQUER) ORIGINATING FROM THE PACKAGING PAPER ITSELF. THIS ADHESIVE IS PRESENT IN THE PAPER AND IS RESPONSIBLE FOR THE ADHESIVENESS BETWEEN THE PAPER AND THE FILM AFTER THE SEALING IN THE PACKAGING MACHINE. ACTION TAKEN -"E.V.A. ETHYLENE VINYL ACETATE: CHANGE OF THE PAPER "OLIVER TOLAS WITH LACQUER " (PAPER CONTAINS ETHYLENE VINYL ACETATE) FOR ARJO / STERIMED ETHYPEL 70G / M2 PAPER (PAPER WITHOUT ETHYLENE VINYL ACETATE, NO LACQUER) WHICH INDIRECTLY CAN AVOID THIS KIND OF FOREIGN MATTER. THE ABOVE ACTIONS, AMONG OTHERS, WERE CARRIED OUT UNTIL NOVEMBER 2017, ACCORDING TO CM #084-15. THE ASSEMBLY BATCH WAS PRODUCED HAS OCCURRED IN FEBRUARY 2015." CATHETER INTEGRITY - A ROOT CAUSE FOR THIS CLAIM WAS NOT ATTRIBUTED, AS THE CLAIMED INCIDENT WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 FOREIGN MATTER WAS ON THE CATHETER OF A BD ANGIOCATH¿ IV CATHETER. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194081 BD ANGIOCATH¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 5036034 30382903811343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other