BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9930141 · Received April 6, 2020

    Report

    Report Number
    1710034-2020-00246
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    March 4, 2020
    Report Date
    May 26, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814443
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED INSYTE AUTOGUARD 18GA UNIT AND AN OPENED EMPTY PACKAGE FROM MATERIAL NUMBER 381444, LOT NUMBER 9190471. THE UNIT CONSISTED OF A RETRACTED NEEDLE/BARREL ASSEMBLY AND A NON-BD CAP. THE CATHETER/ADAPTER ASSEMBLY WAS NOT RETURNED FOR EVALUATION. A VISUAL EVALUATION WAS PERFORMED ON THE RETURNED NEEDLE/BARREL ASSEMBLY. THE NEEDLE WAS PUSHED TO THE OUT POSITION. THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO THE NEEDLE. THE CATHETER/ADAPTER ASSEMBLY WAS NOT RETURNED FOR EVALUATION, THEREFORE THE DEFECT COULD NOT BE INVESTIGATED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CATHETER WAS DISCOVERED TO BE BROKEN WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY A PHONE CALL THAT A CATHETER WAS GIVEN TO HIM AFTER IT HAD FALLEN APART DURING USE. IT DID NOT MAKE IT TO THE PATIENT HOWEVER. I ASKED FOR MORE CLARIFICATION ON THE INCIDENT AND HE SAID ALL HE KNOWS IS THAT IT FELL APART.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE CATHETER WAS DISCOVERED TO BE BROKEN WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY A PHONE CALL THAT A CATHETER WAS GIVEN TO HIM AFTER IT HAD FALLEN APART DURING USE. IT DID NOT MAKE IT TO THE PATIENT HOWEVER. I ASKED FOR MORE CLARIFICATION ON THE INCIDENT AND HE SAID ALL HE KNOWS IS THAT IT FELL APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392840 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381444 9190471 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other