BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE 24GA X 0.75IN

    MDR report key: 19635501 · Received June 28, 2024

    Report

    Report Number
    9610048-2024-00077
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 5, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883110
    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

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. AN ADDITIONAL LOT NUMBER WAS PROVIDED IN THIS COMPLAINT FOR MATERIAL NUMBER 38831114. LOT # 3062305 MNF DATE 2023-03-27 EXP DATE 2028-02-29.

    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 24GA X 0.75IN CATHETER TIP IS NOT SHARP/OTHER ABNORMALITIES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: I WOULD LIKE TO INFORM YOU THAT THE DIFFERENT SERVICES OF THE CLINIC ARE REPORTING ADVERSE EVENTS RELATED TO THE INTRAVENOUS CATHETERS OF SIZES 18, 20, 22 AND 24. THE NURSING STAFF STATES THAT THE CATHETER HAS A LACK OF SHARPNESS AT THE TIP AND OTHER ABNORMALITIES, WHICH MAKES VENOUS ACCESS DIFFICULT, AND IT IS NECESSARY TO PERFORM THE VENIPUNCTURE PROCESS MORE THAN ONCE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. COULD YOU PLEASE CONFIRM THE QUANTITY RELATED TO THIS EVENT FOR EACH LOT 3082670, 3062305? FROM BOTH LOTS MORE THAN 3 CASES WERE REPORTED WHERE MORE THAN ONE VENIPUNCTURE WAS NEEDED TO BE PERFORMED ON THE PATIENT. IS THE SAMPLE RELATED TO THIS EVENT AVAILABLE FOR COLLECTION? YES. FOR SPECIMEN COLLECTION, PLEASE REPORT QUANTITY - (B)(4) CATHETERS. IS THERE ANY OTHER PROBLEM WITH THE SILICONE CATHETER? PART OF THE CATHETER IS KINKED OVER THE NEEDLE AT THE TIME OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206043 BD INSYTE 24GA X 0.75IN PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3082670 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown