BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 20095816 · Received August 29, 2024

    Report

    Report Number
    9610048-2024-00140
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    June 10, 2024
    Report Date
    December 4, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 4051975. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURES AND ONE (1) VIDEO SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. BASED ON THE PICTURE SAMPLES, IT WAS OBSERVED THAT THE CUSTOMER COMPARES THE INSYTE AND ANGIOCATH PRODUCTS SIDE BY SIDE AND PROVIDES PICTURES OF THE INSYTE PRODUCT; HOWEVER, NO DEFECTS ARE OBSERVED THROUGH THE PICTURES ALONE. WITH THE VIDEO SAMPLE, THE CUSTOMER REMOVES THE CATHETER FROM THE NEEDLE AND COMPARES THE FLEXIBILITY OF THE ANGIOCATH AND INSYTE PRODUCTS. ACCORDING TO THE VISUAL ANALYSIS OF THE ATTACHED PHOTOS AND VIDEO, NO DAMAGE WAS OBSERVED TO THE PRODUCT THAT COULD LEAD TO A COMPLAINT. BD INSYTE¿ DEVICES HAVE A RADIOPAQUE BD VIALON¿ CATHETER MADE OF POLYURETHANE AND BD ANGIOCATH¿ DEVICES HAVE A RADIOPAQUE TEFLON CATHETER MADE OF FLUORINATED ETHYLENE PROPYLENE (FEP). THE INSYTE PRODUCT IS INDEED MORE FLEXIBLE THAN THE ANGIOCATH PRODUCT. VIALON (INSYTE PRODUCT) IS A THERMOSENSITIVE MATERIAL AND DOES NOT HAVE MEMORY. THE FEP CATHETER (ANGIOCATH PRODUCT) IS A RIGID MATERIAL AND HAS MEMORY. IT IS WORTH NOTING THAT THE PRODUCT BEING MORE FLEXIBLE IS A CHARACTERISTIC OF THE INSYTE PRODUCT AND IS NOT A DEFECT. A CAUSE FOR ANY MANUFACTURING RELATED ISSUE COULD NOT BE DETERMINED FOR THIS REPORT; HOWEVER, IT IS POSSIBLE THAT THIS ISSUE IS RELATED TO THE CUSTOMER¿S PERCEPTION OF THE USE OF THE RELATED PRODUCTS. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE CATHETER IS 'FLIMSY' BACKS OUT OF VEIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: THIS LINE, UNLIKE THE PREVIOUS ONE, HAS HAD THE FOLLOWING DRAWBACKS: EASE OF LOSS OF ACCESS DUE TO THE GREATER MALLEABILITY OF THE CANNULA, WHICH IS POSITIONED IN THE LUMEN OF THE BLOOD VESSEL. IT HAS BEEN OBSERVED BY NURSING PROFESSIONALS THAT THE INSYTE LINE HAS A MORE MALLEABLE GUIDE (PART LIKE A SILICONE OR NYLON) AND THIS HAS FAVORED THE LOSS OF ACCESS, SINCE THE MORE FLEXIBLE PART COMES OUT OF THE LUMEN MORE EASILY.

    Description of Event or Problem · 0

    ON 09-09-2024, WHAT WAS DONE TO COMPLETE THE PATIENT'S TREATMENT? WAS THERE ANY SERIOUS OR LIFE-THREATENING HARM THAT RESULTED FROM THE REPORTED EVENT? HERE'S THE ANSWER: THE MATERIAL WAS REPLACED WITH THE NO. 24 PERIPHERAL ACCESS CATHETER, BD ANGIOCATH AND OTHER BRANDS THAT WERE IN STOCK. THERE WAS NO SERIOUS OR LIFE-THREATENING DAMAGE. THE REASON FOR REPORTING THE EVENT IS SIMPLY TO UNDERSTAND WHETHER THE CHARACTERISTIC OF THE MATERIAL REPORTED IS PERMANENT OR SPECIFIC TO A BATCH. ALSO, TO FIND OUT IF THE TWO LINES OF MATERIAL WILL CONTINUE TO BE AVAILABLE ON THE MARKET: ANGIOCATH AND INSYTE, SO THAT OUR NEXT PURCHASES CAN BE DIRECTED TOWARDS THE ANGIOCATH LINE, WHICH SERVES US BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314750 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4051975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown