BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8344249 · Received February 15, 2019

    Report

    Report Number
    9610048-2019-00116
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Date of Event
    January 28, 2019
    Report Date
    August 30, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT; NO QNS WERE INITIATED FOR THIS LOT. ALTHOUGH UNITS WERE NOT RETURNED FOR INVESTIGATION, A PHOTO WAS PROVIDED FOR OBSERVATION OF THIS INCIDENT. THE PHOTO SHOWN A CLEAR PLASTIC BAG WHICH CONTAINED A TOP WEB (LABEL) FROM WHAT APPEARED TO BE A 24GA IV PRODUCT. THE PHOTO ALSO SHOWN WITHIN THE CLEAR BAG WHAT APPEARED TO BE AN ADAPTER PORTION OF A 24GA IV UNIT. VISUAL/MICROSCOPIC: OBSERVATION OF THE CONTENTS OF THE CLEAR BAG IN THE PROVIDED PHOTO DID NOT OFFER SUFFICIENT EVIDENCE TO IDENTIFY THE FAILURE OF LEAKAGE THE PHOTO PROVIDED FOR THIS INCIDENT DID NOT REVEAL SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE REPORTED DEFECT OF LEAKAGE; THEREFORE A ROOT CAUSE COULD NOT BE STABLISHED. WITHOUT THE ACTUAL UNIT NOTED IN THIS INCIDENT, THERE WAS NO MECHANICAL/PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    D3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. G1. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SANDY, UT. THE PRODUCT IS MADE IN SANDY, UT AND PACKAGED IN JUIZ DE FORA, BR. THIS REPORT ERRANTLY REPORTED THE MANUFACTURER AS JUIZ DE FORA, BR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKED AND IT OCCURRED IN THE COLORED PART (BETWEEN THE CATHETER AND THE ADAPTER).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER LEAKED AND IT OCCURRED IN THE COLORED PART (BETWEEN THE CATHETER AND THE ADAPTER).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD INSYTE AUTOGUARD SHIELDED IV CATHETER LEAKED AND IT OCCURRED IN THE COLORED PART (BETWEEN THE CATHETER AND THE ADAPTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135434 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8180770 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other