BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18849689 · Received March 6, 2024

    Report

    Report Number
    9610048-2024-00028
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    December 23, 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

    IT WAS REPORTED THAT BD INSYTE CATHETER TIP OPENS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN THE PUNCTURE IS PERFORMED, IT IS EVIDENT THAT THE CATHETER DOES NOT SLIDE. THE CATHETER, ONLY THE TIP OF THE MANDREL AND THE POLYURETHANE IS BLOOM. RECEIVED ON 01MAR2024. WHAT DOES "FLOREA" MEAN? THE TIP OPENS. IS THE CATHETER BENDING OR BUNCHED UP ON ITSELF? IS IT RETRACTING? IS THE CATHETER TIP SPLITTING OR FRAYING? I ATTACH PHOTO SAMPLES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519132 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male