BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 19372453 · Received May 22, 2024

    Report

    Report Number
    9610048-2024-00058
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    February 6, 2024
    Report Date
    July 12, 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
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. CLARIFICATION EFFORTS REMAIN IN PROGRESS RELATED TO TREATMENT OF 'MULTIPUNCTURE' AS DEFINED BY THE CUSTOMER.

    Description of Event or Problem · 0

    COULD YOU PROVIDE US WITH THE CATALOG AND LOT NUMBER? A: 388311 LOTE 3062298. WHAT IS THE DATE OF THE EVENT? A: 6 FEBRERO 2024. WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL (DETAIL)? A: IT IS DETAILED THAT THE PATIENT WAS MULTIPUNCTION CAUSING HIM/HER INJURY WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE EVENT (IMAGING TESTS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) A: IF MEDICAL AND IF THERE WAS A NEED TO CURE THE DAMAGE FROM THE MULTIPUNCTIONS. WHAT IS THE AMOUNT USED AND WAS THE DEFECT IDENTIFIED? A: ONE WAS USED AND DISCARDED. ALSO, COULD YOU CLARIFY WHAT THE ¿FLAT BEVEL¿ REPORTED IN THE INITIAL EMAIL IS? A: FLAT BEVEL MEANS THAT IT DOES NOT HAVE THE TRIBICEL, BUT IT IS WITHOUT IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE CATHETER IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: AT THE MOMENT OF INSERTING THE CATHETER, RESISTANCE IS OBSERVED ON THE SKIN, SO IT IS REMOVED AND THE CATHETER IS OBSERVED OPEN, SO IT IS NOT USED AND IS RETURNED TO STORAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1704826 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3062298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other