BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 19012022 · Received April 1, 2024

    Report

    Report Number
    9610048-2024-00037
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 11, 2024
    Report Date
    September 17, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 3062305 AND 2237018. 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, ONE (1) PICTURE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURE, THE NEEDLES WERE OBSERVED THROUGH THE CATHETERS. BASED ON THE INVESTIGATION RESULTS, IT IS POSSIBLE THAT THIS INCIDENT RESULTED DURING THE ASSEMBLY OF THE PRODUCT, WHERE A FAILURE IN THE VISION SYSTEM ALLOWED A TRANSFIXED CATHETER TO BE RELEASED TO THE CUSTOMER. HOWEVER, IF THE CATHETER WAS TRANSFIXED PRIOR TO PUNCTURE, IT WOULD NOT HAVE BEEN USEABLE. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THE DEFECT OF NEEDLE THROUGH CATHETER AND PREVENT ANY FUTURE REOCCURRENCE. 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: 11/03/2024 THERE WAS AN ADVERSE EVENT WITH A 9 YEAR OLD PATIENT WITH CLONIDINE TEST, WHEN TRYING TO CANALIZE IT AND INTRODUCE THE NEEDLE IN THE VEIN THE HELMET OPENED WHILE INSIDE PREVENTING THE CORRECT CANALIZATION, WE TRIED AGAIN WITH A NEW HELMET AND IN A DIFFERENT ARM AND EXACTLY THE SAME THING HAPPENED.

    Description of Event or Problem · 0

    (B)(6) 2024. HAS THERE BEEN ANY HARM TO PATIENTS/HEALTHCARE PROFESSIONALS? YES, THERE HAVE BEEN DIFFERENT EFFECTS ON PATIENTS, AMONG WHICH, ON MONDAY, (B)(6), THE INPUT WAS USED FOR THE ACQUISITION OF THE SAMPLE, HOWEVER, THE HELMET OPENS INSIDE THE PATIENT GENERATING DISCOMFORT AND A BAD REACTION, WHERE THEIR VITAL SIGNS DECREASE AND THEIR BLOOD PRESSURE DROPS DRASTICALLY. PREVENTING THE CONTINUATION OF THE EXAMINATION IN A SATISFACTORY MANNER. IS THERE A PATIENT INVOLVED, PLEASE CONFIRM? YES. WHEN DID THE INCIDENT OCCUR, BEFORE, AFTER, OR DURING THE PROCEDURE? DURING THE PROCEDURE. -I HAVE SEEN IN THE IMAGES PROVIDED THAT THE LOT 2237018 HAS ALSO BEEN NOTIFIED, IS IT RELATED TO THIS ONE (THE PLASTIC COVERING THE NEEDLE IS SEPARATE FROM IT (AND HAD BEEN NOTIFIED IN (B)(6) 2023 AND (B)(6) 2024). IF YES, WHEN DID THIS EVENT OCCUR, EXACT DATE, PLEASE. THERE HAVE BEEN NEWS WITH THE BATCHES, HOWEVER, DUE TO THE TIME THAT HAS ELAPSED WE NO LONGER HAVE EVIDENCE OF THE AFFECTATION, IN ADDITION THESE NEWS HAVE BEEN REPORTED ON SEVERAL OCCASIONS, PLEASE CHECK THE TRACEABILITY OF WHAT WAS REPORTED. -PLEASE CONFIRM HOW MANY BATCHES ARE AFFECTED. TWO LOTS: 3062305 AND 2237018. -WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENCE (IMAGING TESTS, SURGERY, DRUG ADMINISTRATION, ETC.)? (DETAIL) THE PATIENT IS REFERRED TO ONE OF THE LOCATIONS WHERE THE LABORATORY HAS MEDICAL PERSONNEL TO ATTEND TO THESE CASES, HOWEVER, IT IS IMPORTANT TO MENTION THAT THIS SITUATION SHOULD NOT OCCUR IF THE SUPPLY WORKS CORRECTLY. BECAUSE HARM IS CAUSED TO A PATIENT, THE APPROPRIATE REPORT IS MADE TO INVIMA AS AN ADVERSE EVENT. - WAS THERE BLOOD/CHEMOTHERAPY EXPOSURE TO MUCOUS MEMBRANES (EYES, NOSE, AND MOUTH) OR SKIN? IF YES, PLEASE INDICATE WHETHER THE EXPOSURE WAS FROM THE PATIENT OR THE PRACTITIONER AND WHAT ACTIONS WERE TAKEN. (DETAIL) NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1566301 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3062305

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Unknown