BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10902059 · Received November 25, 2020

    Report

    Report Number
    1710034-2020-00751
    Event Type
    Malfunction
    Date Received
    November 25, 2020
    Date of Event
    September 30, 2020
    Report Date
    February 8, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826446
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382644 BATCH NO: UNKNOWN (REPORTED IN VALID LOT # OF 0132431). IT WAS REPORTED THAT THE SAFETY MECHANISM FAILED. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: DESCRIBE THE EVENT OR PROBLEM: SAFETY ON 18G BD IV CATHETER DID NOT DEPLOY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : IV PLACEMENT FOR SURGERY. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; QUESTIONS/INQUIRIES:

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: AN INVALID LOT # WAS PROVIDED AS (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER EXPERIENCED A NEEDLE THAT WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382644, BATCH NO: UNKNOWN (REPORTED IN VALID LOT # OF (B)(4)) IT WAS REPORTED THAT THE SAFETY MECHANISM FAILED. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: DESCRIBE THE EVENT OR PROBLEM: SAFETY ON 18G BD IV CATHETER DID NOT DEPLOY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE : IV PLACEMENT FOR SURGERY. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; QUESTIONS/INQUIRIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367134 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382644 UNKNOWN 30382903826446

    Patients

    Seq Age Sex Outcome Treatment
    1