BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 15758195 · Received November 9, 2022

    Report

    Report Number
    1710034-2022-00667
    Event Type
    Malfunction
    Date Received
    November 9, 2022
    Date of Event
    October 13, 2022
    Report Date
    December 9, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLES IN 10 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WOULD NOT RETRACT WHEN STARTING THE IV ACCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAVE HAD MULTIPLE CATHETERS ALL FROM LOT#2160587 THAT DO NOT RETRACT THE NEEDLE WHEN THE BUTTON IS PRESSED. THEY CURRENTLY HAVE 640EA OF THE DEFECTIVE PRODUCT WITH LOT# 2160587. WHAT WAS THE PRODUCT BEING USED FOR WHEN THE REPORTED ISSUE WAS NOTICED? STARTING IV ACCESS. WAS THE PROCEDURE ABLE TO BE COMPLETED? YES. WAS THERE ANY IMPACT/HARM TO THE PATIENT, DUE TO THE REPORTED ISSUE? NO HARM. WAS THERE ANY MEDICAL INTERVENTION OR TREATMENT NEEDED DUE TO THE ISSUE PATIENT EXPERIENCED? NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLES IN 10 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS WOULD NOT RETRACT WHEN STARTING THE IV ACCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY HAVE HAD MULTIPLE CATHETERS ALL FROM LOT#2160587 THAT DO NOT RETRACT THE NEEDLE WHEN THE BUTTON IS PRESSED. THEY CURRENTLY HAVE 640EA OF THE DEFECTIVE PRODUCT WITH LOT# 2160587. WHAT WAS THE PRODUCT BEING USED FOR WHEN THE REPORTED ISSUE WAS NOTICED? STARTING IV ACCESS. WAS THE PROCEDURE ABLE TO BE COMPLETED? YES. WAS THERE ANY IMPACT/HARM TO THE PATIENT, DUE TO THE REPORTED ISSUE? NO HARM. WAS THERE ANY MEDICAL INTERVENTION OR TREATMENT NEEDED DUE TO THE ISSUE PATIENT EXPERIENCED? NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2650081 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381434 2160587 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown