BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 20036035 · Received August 22, 2024

    Report

    Report Number
    9610048-2024-00133
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 22, 2024
    Report Date
    November 25, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883110
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, THE NEEDLE WAS OBSERVED THROUGH THE CATHETER COMPONENT. IT IS WORTH NOTING THAT THE CATHETER COMPONENT APPEARED TO CONTAIN BLOOD AND IF THE PRODUCT WAS AFFECTED DURING MANUFACTURE, THE USE OF THE PRODUCT WOULD NOT HAVE BEEN POSSIBLE. IT IS POSSIBLE THAT THIS INCIDENT RESULTED DURING THE USE OF THE PRODUCT. WHEN THE 360-DEGREE ROTATION IS PERFORMED, THE CATHETER MAY BE PUSHED FORWARD, CAUSING THE CATHETER TO BECOME TRANSFIXED BY THE NEEDLE DURING PUNCTURE. THIS TYPE OF DEFECT CAN RESULT DURING THE MANUFACTURING PROCESS, IF THERE IS A FAILURE IN THE VISION DETECTION SYSTEM; HOWEVER, IF THE CATHETER WAS TRANSFIXED DURING MANUFACTURE, THE USE OF THE PRODUCT WOULD NOT BE POSSIBLE. A PREVIOUS CORRECTIVE AND PREVENTIVE ACTION PLAN WAS COMPLETED TO REDUCE THE RISK OF THIS POTENTIAL DEFECT; THIS LOT WAS MANUFACTURED PRIOR TO THE PLANS COMPLETION. 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 NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: IT IS PUNCTURED WITHOUT INCIDENT, THE VEIN IS CANNULATED AND WHEN TRYING TO INTRODUCE TEFLON AND REMOVE THE NEEDLE, AN INCREASE IN VOLUME IS OBSERVED AT THE INSERTION SITE, AN ATTEMPT IS MADE TO REMOVE THE ENTIRE CATHETER WITHOUT SUCCESS, THEN THE NEEDLE IS REMOVED FIRST, AND A BROKEN TEFLON IS OBSERVED, WHICH SHOWS MATERIAL FATIGUE. REMOVAL OF VASCULAR ACCESS, NEW ACCESS INSTALLED, WITHOUT INCIDENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED (B)(6) 2024: "AN INCREASE IN VOLUME IS OBSERVED AT THE INSERTION SITE" COULD YOU CONFORM THE INCREASE IN VOLUME IS BLOOD RELATED? YES, BLOOD RELATED. COULD YOU TELL ME IF UPON REMOVAL OF THE CATHETER NEEDLE AND CATHETER WERE STICKY? THEY WERE NOT STICKY. DID YOU OBSERVE ANY VISIBLE DAMAGE BEFORE STARTING THE PROCEDURE? NONE, PROCEDURE WAS PERFORMED ACCORDING TO RECENT BD TRAINING (TAKE OFF MANDREL ROTATING, NOT ADVANCING AND RETREATING). ANY DIFFICULTIES DURING INSERTION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28801 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 4051975 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown