BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 17600602 · Received August 23, 2023

    Report

    Report Number
    9610048-2023-00086
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    July 27, 2023
    Report Date
    November 22, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3082675. 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, TWO (2) PICTURES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, THE NEEDLE WAS OBSERVED THROUGH THE CATHETER. IT IS POSSIBLE THAT THIS DEFECT RESULTED FROM A MALADJUSTMENT IN THE AIR BLOWING FITTINGS IN THE MANUFACTURING PROCESS IN RELATION TO THE CATHETER LENGTH. IT IS ALSO PROBABLE THAT THE VISION SYSTEM WAS NOT PROPERLY CONFIGURED. 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.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H3. 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 · 0

    WE ARE NOSO INSYTE AUTOGUARD 24GAUGEX0.75PG REFERENCE (B)(4). BATCH: 3082675. THE MATERIAL'S SILICONE IS TEARING DURING THE PUNCTURE, IT DOES NOT SLIDE INTO THE PATIENT'S VEIN; HERE ARE IMAGES OF THE MATERIAL, HAVING TECHNICAL PROBLEMS WITH THE USE OF THE ITEM: CATETER INTRAVE WE ALREADY HAD SOME EVENTS IN THE INSTITUTION FROM NURSING RELATED TO THIS EVENT. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION. THE INCIDENT OCCURRED DURING USE, AT THE TIME OF THE PUNCTURE. THERE WAS NO DAMAGE, BUT A NEW PUNCTURE IS NECESSARY. THERE WAS NO NEED FOR MEDICAL INTERVENTION. THERE WAS NO BLOOD EXPOSURE. AS FOR MEDICATIONS, THEY WERE NOT ADMINISTERED, AS WE NEEDED ACCESS BEFOREHAND. THIS DOES NOT OCCUR WHEN THE ABOCATH IS ALREADY POSITIONED, BUT RATHER AT THE TIME OF THE PUNCTURE. I INFORM YOU THAT THE NON-RESPONSE OCCURRED BECAUSE THE NURSE RESPONDED ONLY TO US AND DID NOT COPY IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE NEEDLE WENT THROUGH THE CATHETER. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THE MATERIAL'S SILICONE IS TEARING DURING THE PUNCTURE, IT DOES NOT SLIDE INTO THE PATIENT'S VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812484 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON IND. CIRURGICAS LTDA 3082675

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown