BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18639331 · Received February 5, 2024

    Report

    Report Number
    9610048-2024-00006
    Event Type
    Malfunction
    Date Received
    February 5, 2024
    Date of Event
    January 10, 2024
    Report Date
    May 7, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38831114 AND LOT NUMBER 3062305. ALTHOUGH NO QUALITY NOTIFICATIONS OR NON-CONFORMITY REPORTS WERE DOCUMENTED DURING THE PRODUCTION PROCESS, A CORRECTIVE MAINTENANCE ACTION WAS PERFORMED DURING THE MANUFACTURING PERIOD. THE MAINTENANCE ACTION PERFORMED VARIOUS ADJUSTMENTS AND ALIGNMENTS THAT MAY HAVE BEEN RELATED TO THIS DEFECT. AS SAMPLES WERE UNAVAILABLE FOR THIS EVENT, A THOROUGH SAMPLE ANALYSIS COULD NOT BE COMPLETED. IT WAS DETERMINED THAT THE PROBABLE ROOT CAUSE IS RELATED TO THE FORMATION OF THE CATHETER TIP IN THE ASSEMBLY PROCESS. 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.

    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. A.2. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD.

    Description of Event or Problem · 0

    RESPONSE RECEIVED ON 24JAN2024. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENCE (IMAGING TESTS, SURGERY, ADMINISTRATION OF DRUGS, ETC.)? (DETAIL) NO ADDITIONAL PROCEDURES REQUIRED WAS THERE ANY EXPOSURE OF BLOOD/CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF YES, INDICATE WHETHER THE EXPOSURE WAS FROM THE PATIENT OR THE PRACTITIONER AND WHAT MEASURES WERE TAKEN. (DETAIL) THERE WAS NO EXPOSURE TO BLOOD OR OTHER INTERNAL AGENT. WHAT MEDICATION WAS BEING ADMINISTERED? NO INFORMATION RELATED, THE MEDICATION HAD NOT YET BEEN ADMINISTERED TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE THE CATHETER BREAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WHEN THE PATIENT IS CANNULATED, THE CATHETER BURSTS AND IT IS NECESSARY TO PUNCTURE THE PATIENT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1595782 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3062305

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female