BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 18740152 · Received February 20, 2024

    Report

    Report Number
    9610048-2024-00020
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    January 25, 2024
    Report Date
    July 15, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    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

    ADDITIONAL INFORMATION RECEIVED REGARDING PATIENT OUTCOME. SEE TAB B DESCRIPTION.

    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. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, THE NEEDLE WAS OBSERVED THROUGH THE CATHETER COMPONENT. THIS DEFECT MAY BE RELATED TO PRODUCT ASSEMBLY, IF THERE WAS A FAILURE IN THE VISION SYSTEM, WHICH ALLOWED A TRANSFIXED CATHETER TO BE RELEASED; HOWEVER, IF THE CATHETER WAS TRANSFIXED BEFORE USE, IT WOULD NOT BE POSSIBLE TO ADVANCE THE CATHETER. A CORRECTIVE AND PREVENTIVE ACTION PLAN HAS BEEN INITIATED FOR THE DEFECT OF NEEDLE THROUGH CATHETER, TO FURTHER INVESTIGATE THE POSSIBLE CAUSES AND PREVENT ANY REOCCURRENCE.

    Description of Event or Problem · 0

    RESPONSE RECEIVED ON 19FEB2024. HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTH PROFESSIONAL (DETAIL)? IT WAS NOT POSSIBLE TO TAKE THE SAMPLE DUE TO THE CONDITIONS OF THE INPUT. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENCE (IMAGING TESTS, SURGERY, DRUG ADMINISTRATION, ETC.)? (DETAIL) NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE NEEDLE PIERCE THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: CUSTOMER HAS QUALITY PROBLEMS WITH INSYTE CATHETERS 24GA X 0.75. AS YOU CAN SEE IN THE PICTURES THE CATHETER BREAKS AND DETACHES FROM THE NEEDLE. IT HURTS THE PATIENT AND THE CANNULATION IS NOT PERFORMED CORRECTLY, ADDITIONALLY IN OTHER CASES THE PRODUCT IS NOT USED DUE TO DEFECTIVE INPUT.

    Description of Event or Problem · 0

    AS RESPONSE RECEIVED ON 15APR2024. (B)(4) UNITS WERE IDENTIFIED AS DEFECTIVE PRODUCT, WHICH IS WHY THE (B)(4) UNITS THAT WERE IN INVENTORY HAVE BEEN IDENTIFIED AS NON-CONFORMING PRODUCT AND ARE IN QUARANTINE AWAITING A RESPONSE FROM YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1085521 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3062305

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown