BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE

    MDR report key: 21495723 · Received February 28, 2025

    Report

    Report Number
    9610048-2025-00018
    Event Type
    Injury
    Date Received
    February 28, 2025
    Date of Event
    October 17, 2024
    Report Date
    June 5, 2025
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831414 AND LOT NUMBER 4018908, 4051978, 4079675 & 4018908. 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. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. PER THE PROVIDED FEEDBACK, IT IS POSSIBLE THAT THE USE OF THE PRODUCT HAD AN IMPACT IN THIS EVENT. 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

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

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE CATHETER BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: NURSE WHEN INSTALLING VVP 20 IN LEFT FOREARM, TEFLON ADVANCES THROUGH THE VEIN AND PRESENTS STOP (STOPPING REFLUX), REMOVES NEEDLE AND WHEN SHE IS GOING TO REMOVE THE TEFLON, SHE FEELS DIFFICULTY, ANOTHER COLLEAGUE REMOVES IT AND NOTICES THAT THE TEFLON IS SHORTER THAN USUAL, SHE IS LEFT WITH THE DOUBT IF IT CAME WITH FACTORY FAILURE OR A PART WAS LEFT IN THE PATIENT, ON PALPATION NO FOREIGN BODY IS FELT. SINCE WE ARE NOT SURE AND ACCORDING TO THE INDICATION OF THE HEAD PHYSICIAN OF OUTPATIENT PROCEDURES, THE PATIENT IS TRANSFERRED TO THE EMERGENCY DEPARTMENT FOR EVALUATION BY THE SURGEON. NURSE REMOVES WRAPPER AND TEFLON, THEREFORE, WE CANNOT KNOW EXACTLY WHAT WAS THE BATCH OF THE INPUT. IN THE EMERGENCY DEPARTMENT THEY PERFORM ECHO IN THE FOREARM. (B)(6) 2025 IS THERE ANY IMPACT ON THE PATIENT? IF YES, PLEASE DESCRIBE IT IN DETAIL. THE PATIENT WAS TAKEN TO IMAGING, SOFT TISSUE ULTRASOUND WAS PERFORMED, NO RADIOLUCENT MATERIAL WAS FOUND IN SUBCUTANEOUS TISSUE . COULD YOU SHARE ANY PHOTOS/VIDEOS RELATED TO THIS EVENT? NO PHOTOGRAPHIC OR VIDEO INFORMATION IS AVAILABLE. COULD YOU CONFIRM THE DATE ON WHICH THE EVENT OCCURRED? (B)(6) 2024 AT 17:00. AGE, SEX, WEIGHT, ETHNICITY, AND/OR RACE OF THE PATIENT? AGE: 63 YEARS OLD - GENDER: FEMALE - WEIGHT, ETHNICITY AND/OR RACE: UNKNOWN. WHAT IS THE PATIENT'S CURRENT CONDITION? LAST CARE REGISTERED AT CLINICA INDISA PROVIDENCIA ON (B)(6) 2025 IN THE GENERAL EMERGENCY SERVICE CONSULTATION FOR A KNOWN DOG BITE ON THE RIGHT HAND. DID THE PATIENT HAVE ANY SYMPTOMS DUE TO THE BREAK/LEAK? PAIN WHEN REMOVING THE CHUCK CATHETER WITH THE CUT POLYURETHANE. WERE ANY EXTRAVASATIONS OR INFILTRATIONS IDENTIFIED? NO. WAS THE DEVICE EMBOLIZED IN THE PATIENT? NO. WHAT MEDICATION WAS BEING ADMINISTERED? MIDAZOLAM, FENTANIL (ENDOSCOPIA). HOW WAS TEFLON REMOVED FROM THE PATIENT'S BODY? NURSE, WHEN INSTALLING A 20G CATHETER IN THE LEFT FOREARM, ADVANCES TEFLON THROUGH THE VEIN AND PRESENTS A STOP (STOPPING REFLUX), WITHDRAWS THE NEEDLE AND WHEN SHE GOES TO REMOVE THE TEFLON, SHE FEELS DIFFICULTY, ANOTHER COLLEAGUE REMOVES IT AND THEY REALIZE THAT THE TEFLON IS SHORTER THAN USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661081 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female