BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD YEL 24GA X 0.75IN

    MDR report key: 19536878 · Received June 14, 2024

    Report

    Report Number
    9610048-2024-00069
    Event Type
    Malfunction
    Date Received
    June 14, 2024
    Date of Event
    February 21, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 38182314 AND LOT NUMBER 3241292. 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. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. 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

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    EVENT 1: NQT-001313 - PRAIA GRANDE UNIT SAME REFERENCE, BATCH 32411292 "THE BD BRAND ABBOCATH IS DIFFICULT TO PUNCTURE, BECAUSE WHEN THE BEVEL IS INSERTED, IT DOES NOT GLIDE IDEALLY ON THE SKIN, CAUSING DISCOMFORT TO THE PATIENT, IN ADDITION TO THE FACT THAT THERE IS NO CONSISTENT LOCK BETWEEN THE LUMEN AND THE PROBE, WHICH LOOSENS EASILY, WHEN TRYING TO ALIGN THE PROBE, IT BREAKS THE LUMEN, CAUSING VENOUS RUPTURE." HOW MANY PRODUCTS HAVE BEEN AFFECTED, PLEASE CONFIRM THE QUANTITY? ONLY ONE UNIT OF EACH BATCH MENTIONED IN THE NOTIFICATIONS, A TOTAL OF 5 UNITS. HAS THERE BEEN ANY HARM TO PATIENTS/HEALTH PROFESSIONALS? NO HAVE PATIENTS BEEN INVOLVED, PLEASE CONFIRM? YES, BUT THERE WAS NO HARM. COULD YOU SEND PHOTO SAMPLES/VIDEOS OF THE SAMPLE? IT WAS NOT SENT IN THE NOTIFICATIONS. WHEN DID THIS EVENT OCCUR, BEFORE, AFTER OR DURING THE PROCEDURE? DURING THE PROCEDURE. DATE OF THE EVENT? 22/02/24, 21/02/24, 20/02/24, 11/01/24. 32411292 THIS BATCH DOES NOT MATCH THE MATERIAL NUMBER ENTERED. PLEASE PROVIDE THE CORRECT LOT OR CATALOG NUMBER. 3241292 CORRECT BATCH NUMBER RECEIVED ON 27TH MAY2024

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368460 INSYTE AUTOGUARD YEL 24GA X 0.75IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 3241292 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown