BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18849693 · Received March 6, 2024

    Report

    Report Number
    9610048-2024-00027
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    December 25, 2023
    Report Date
    July 10, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    MDS-24-5036-FA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D. THE LOT NUMBER 3062305 PROVIDED CANNOT BE VERIFIED IN ASSOCIATION WITH THE REPORTED MATERIAL NUMBER. 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

    BASED ON THE PROVIDED INFORMATION, IT HAS BEEN DETERMINED THAT THIS INCIDENT IS RELATED TO THE CATHETER TIP NOT BEING COMPLETELY FORMED DURING THE MANUFACTURING PROCESS. WE ARE CONDUCTING A VOLUNTARY RECALL OF THE AFFECTED CATHETERS BD INSYTE FOR CERTAIN CATALOGS AND LOT NUMBERS. THE AFFECTED CATHETER TIP MAY RESULT IN RESISTANCE WITH THE CATHETER INSERTION PROCESS. THE POTENTIAL IMMEDIATE HEALTH CONSEQUENCES ASSOCIATED WITH THE ABOVE, INCLUDE PAIN /DISCOMFORT, VESSEL INJURY, VASCULITIS, TISSUE INJURY, BLEEDING, DELAY IN PROCEDURE AND NEED FOR ADDITIONAL DEVICE INSERTION. IT IS ALSO POSSIBLE FOR THERE TO BE NO HEALTH EFFECTS RELATED TO THE USE OF THE STRAIGHT EDGED TIP. LONG TERM HEALTH CONSEQUENCES WOULD NOT BE EXPECTED; HOWEVER, MAY BE PRESENT ONLY AS A RESULT OF THE IMMEDIATE HEALTH CONSEQUENCE. IT IS RECOMMENDED THAT CLINICIANS USE STANDARD CLINICAL PRACTICE OF INSPECTION OF THE DEVICE PRIOR TO INSERTION. IF THE CLINICIAN DOES NOT NOTICE THE CATHETER TIP EDGE, THEY ARE INSTRUCTED TO STOP THE INSERTION PROCEDURE IF PAIN OR RESISTANCE OUT OF PROPORTION TO THE PROCEDURE IS NOTED. IF A DEFECTIVE PRODUCT IS INSERTED, MONITORING FOR TISSUE, VESSEL AND SKIN DAMAGE IS RECOMMENDED. IF ANY SYMPTOMS OCCUR, IT IS RECOMMENDED TO REMOVE THE PRODUCT AND REPLACE WITH A NEW PRODUCT IF CLINICALLY INDICATED. WE ARE INVESTIGATING AND WILL IMPLEMENT APPROPRIATE MEASURES TO PREVENT RECURRENCE OF THIS PRODUCT ISSUE. A CORRECTIVE AND PREVENTIVE ACTION PLAN IS IN PROGRESS. PRODUCTION PERSONNEL HAVE BEEN INFORMED OF THE PRODUCT ISSUE AND RETRAINED TO THE PROCEDURES TO INCREASE AWARENESS. PLEASE SEE THE PROVIDED RECALL NOTICE (MDS-24-5036-FA) FOR FURTHER INFORMATION.

    Description of Event or Problem · 0

    WHEN THE PUNCTURE IS PERFORMED, IT IS EVIDENT THAT THE CATHETER DOES NOT SLIDE. CATHETER SLIPS, ONLY THE TIP OF THE MANDREL AND THE POLYURETHANE 3 CATHETERS WERE USED. RECEIVED ON 01MAR2024. WHAT DOES "FLOREA" MEAN? THE TIP OPENS.

    Description of Event or Problem · 0

    DURING CANNULATION, WHILE TRYING TO INSERT THE POLYURETHANE, IT RETRACTS TO THE MIDDLE OF THE GUIDEWIRE, WHICH DOES NOT ALLOW CANNULATION OF THE VENOUS ACCESS. DURING THE PUNCTURE OF THE PATIENT, THE NEEDLE ENTERS, BUT WHEN THE SOFT PART OF THE CATHETER ENTERS, IT WRINKLES. ATTEMPTED CANNULATION OF PERIPHERAL VENOUS ACCESS, DYSFUNCTION OF THE CATHETER IS EVIDENCED AT THE TIME OF PUNCTURING THE PATIENT. THE PLASTIC PART OF THE CATHETER IS WRINKLED AT THE TIME OF PUNCTURE. MULTIPUNCTURES ARE PERFORMED BECAUSE CATHETERS NO 24 ARE OF POOR QUALITY, THE MATERIAL IS REGOGE WHEN PERFORMING THE PUNCTURE AND WHEN UNCOVERING IT IS FOUND TO BE BLOOMED WHEN PERFORMING THE PUNCTURE, IT IS EVIDENT THAT THE CATHETER DOES NOT SLIDE, ONLY THE TIP OF THE MANDREL AND THE POLYURETHANE IS BLOOMING. WHEN CANNULATING THE PATIENT, THE CATHETER RETRACTS WHEN PUNCTURING AND OPENS. WHEN PERFORMING THE PUNCTURE, IT IS EVIDENT THAT THE CATHETER DOES NOT SLIDE, ONLY THE TIP OF THE MANDREL AND THE POLYURETHANE IS BLISTERED. AT THE TIME OF CANNULATION, THE BEVEL ENTERS BUT THE CATHETER DOES NOT ENTER, IT WRINKLES AND DOES NOT ALLOW ENTRY. AT THE TIME OF PUNCTURE FOR CANNULATION, THE BEVEL ENTERS, CROSSES THE SKIN BARRIER BUT THE CATHETER BENDS AND DOES NOT ENTER. IT IS OBSERVED THAT WHEN PUNCTURING THE POLYURETHANE DOES NOT SLIDE AND OPENS, ANOTHER INTRAVENOUS CATHETER PERIPHERAL 24 IS USED AND THE SAME SITUATION IS OBSERVED. MULTIPUNCTURE BY CATHETER WITH FORCED TRACTION ON ENTRY AND THERE IS EVIDENCE OF A WRINKLE IN THE CATHETER. WHEN PERFORMING THE PUNCTURE FOR CANNULATION, THE CATHETER IS OBSERVED TO BE DYSFUNCTIONAL, THE POLYURETHANE DOES NOT SLIDE, DOES NOT ADVANCE AND OPENS. AT THE TIME OF PERFORMING PERIPHERAL CANNULATION, THE CATHETER IS DAMAGED, IT IS REMOVED FROM THE PUNCTURE SITE AND THE TIP OF THE DAMAGED CATHETER IS EVIDENT. AT THE TIME OF PERIPHERAL CANNULATION, THE TIP OF THE CATHETER IS BROKEN. -- WHAT DOES "FLOREA" MEAN? FOR EXAMPLE: THE TIP OPENS. IS THE CATHETER BENDING OR BUNCHED UP ON ITSELF? IS IT RETRACTING?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519136 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male