BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18664126 · Received February 7, 2024

    Report

    Report Number
    9610048-2024-00014
    Event Type
    Malfunction
    Date Received
    February 7, 2024
    Date of Event
    January 15, 2024
    Report Date
    April 28, 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

    TWO (2) PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION, THE PICTURES WERE SUFFICIENT IN CONFIRMING THE ISSUE OF POORLY FORMED CATHETER TIP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3062305. THE REVIEW DID REVEAL A DETECTED ISSUE WITH THE CATHETER TIPPING PROCESS DURING SUB-ASSEMBLY THAT MAY BE RELATED TO THIS EVENT. ADJUSTMENTS HAD BEEN MADE RELATED TO THE CATHETER TIP TO IMPROVE THE PRODUCT QUALITY AND THE RECORDS SHOW THESE ADJUSTMENTS WERE CARRIED OUT PER PROCEDURES BY THE AREA OPERATORS. IT HAS BEEN DETERMINED THAT THE OBSERVED DEFECT RESULTED DURING THE FORMATION OF THE CATHETER TIP IN THE ASSEMBLY PROCESS. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS TYPE OF DEFECT AND PREVENT ANY REOCCURRENCE.

    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

    RESPONSE RECEIVED ON 17 JAN2024. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENCE (IMAGING TESTS, SURGERY, ADMINISTRATION OF MEDICATION, ETC.)? (DETAIL) NO, THE SITUATION GENERATED NON-SERIOUS ADVERSE EVENTS ASSOCIATED WITH MULTI-PUNCTURE, WHICH IMPROVED WITH PHYSICAL MEANS AND NON-SERIOUS INCIDENTS WITH PRIOR IDENTIFICATION OF THE NOVELTY. WAS THERE EXPOSURE OF BLOOD/CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF YES, WAS THE EXPOSURE OF THE PATIENT OR THE PRACTITIONER AND WHAT MEASURES WERE TAKEN? (DETAIL) NONE WHAT MEDICATION WAS BEING ADMINISTERED? FAILURE WAS IDENTIFIED DURING THE CATHETERISATION PROCESS WITHOUT INITIATION OF MEDICATION ADMINISTRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE CATHETER TIP IS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WE HAVE OBSERVED THAT THE PART CALLED "FIADOR" PRESENTS A DIFFERENT DESIGN TO THE USUAL ONE, GENERATING ADVERSE EVENTS IN PATIENTS ASSOCIATED TO THE MULTIPLE PUNCTURES DUE TO THE DIFFICULTY OF NAVIGATION OF THE CATHETER IN THE VASCULAR TRAJECTORY AND LOSS OF THE MEDICAL DEVICE. ATTACHED YOU WILL FIND AN IMAGE THAT COMPARES THE DIFFERENCES BETWEEN THE REGULAR DESIGN AND THE NOVELTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440011 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3062305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown