BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18965326 · Received March 23, 2024

    Report

    Report Number
    9610048-2024-00033
    Event Type
    Malfunction
    Date Received
    March 23, 2024
    Date of Event
    February 23, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883110
    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

    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

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3062305. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS NEITHER PHYSICAL SAMPLES NOR PICTURE SAMPLES WERE AVAILABLE FOR RETURN, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IF THE AFFECTED SAMPLES BECOME AVAILABLE FOR THIS INCIDENT OR ANY POTENTIAL FUTURE INCIDENTS, WE WOULD GREATLY APPRECIATE THE OPPORTUNITY TO REVIEW THEM. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED EVENT. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE AND PREVENT ANY REOCCURRENCE. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM TO ENGLISH: A NEWBORN CHANNELING PROCEDURE WAS BEING CARRIED OUT AT THE TIME OF UNCOVERING THE INPUT, IT IS OBSERVED THAT THE YELCO #24 IS IN POOR CONDITION, SINCE IT WAS PERFORATED, FOR THIS REASON ANOTHER DEVICE MUST BE USED LOT 3062305 EXPIRES 02/2028 DEVICE IS REPORTED WITH PHARMACY. DELAY IN PROCEDURE AND TREATMENT: ADDITIONAL INFORMATION RECEIVED ON 03/13/2024 HAS THERE BEEN ANY HARM TO PATIENTS/HEALTHCARE PROFESSIONALS? A: THE EVENT WAS CLASSIFIED AS A NON-SERIOUS ADVERSE EVENT, BECAUSE THE PATIENT EXPERIENCED REDNESS WHICH SUBSIDED OVER TIME WITHOUT THE NEED TO RESORT TO PHYSICAL OR PHARMACOLOGICAL MEANS. IS THERE ANY PATIENT INVOLVEMENT, PLEASE CONFIRM? A: NONE. WHEN DID THIS EVENT OCCUR, BEFORE, AFTER OR DURING THE PROCEDURE? A: DURING THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864093 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3062305 00382903883110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown