BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE

    MDR report key: 20238409 · Received September 17, 2024

    Report

    Report Number
    9610048-2024-00150
    Event Type
    Malfunction
    Date Received
    September 17, 2024
    Date of Event
    July 17, 2024
    Report Date
    October 22, 2024
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903883127
    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 38831214 AND LOT NUMBER 3185090. 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, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, THE DEFECT OF NEEDLE THROUGH CATHETER WAS OBSERVED. NONE OF THE OTHER REPORTED ISSUES WERE OBSERVED THROUGH THE PROVIDED PICTURES. FOR THE OTHER REPORTED INCIDENTS, THE PRODUCTION HISTORY RECORDS WERE UNABLE TO IDENTIFY ANY POSSIBLE CAUSES AND WITHOUT ANY SAMPLES OR PICTURES, WE WERE UNABLE TO REPRODUCE THE REPORTED ISSUES. AT THIS TIME, ADDITIONAL CAUSES COULD NOT BE DETERMINED. 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 CATHETER IS ROUGH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: WE REPORT CATHETER NUMBER 22 BD, REFERENCE (B)(4) INVIMA 2015DM-0003510-R1. - WHEN THE VEIN IS CANNULATED AND THE MANDREL IS REMOVED THE BLOOD IS IMMEDIATELY RETURNED. - THE CATHETER IS TOO ROUGH TO CANNULATE THE PATIENTS. - WHEN ADVANCING THE CATHETER IT IS VERY UNSTABLE AND EASILY DAMAGES THE VEIN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2505813 BD INSYTE PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 3185090 00382903883127

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown