BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15353781 · Received September 4, 2022

    Report

    Report Number
    1710034-2022-00478
    Event Type
    Malfunction
    Date Received
    September 4, 2022
    Date of Event
    August 11, 2022
    Report Date
    October 11, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE LOT #: AN INVALID LOT # OF 2022708 WAS PROVIDED BY THE INITIAL REPORTER. DEVICE EXPIRATION DATE: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D10: RETURNED TO MANUFACTURER ON: 21SEP2022. H6: INVESTIGATION SUMMARY: BD RECEIVED TWO UNSEALED 20 GAUGE INSYTE AUTOGUARD BLOOD CONTROL DEVICES FROM LOT 2022708 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED THAT BOTH UNITS HAD BENT NEEDLES. THE UNITS WERE ALSO PARTIALLY RETRACTED. NEXT, MICROSCOPIC ANALYSIS WAS PERFORMED ON THE NEEDLE COVER BUT COULD NOT IDENTIFY ANY SCRATCHES OR DAMAGE TO THE COVER. THE ENGINEER ALSO IDENTIFIED AN ISSUE WITH THE PRODUCT PACKAGING NOTING A TEAR IN THE TOP WEB THAT WOULD COINCIDE WITH THE END OF EACH BARREL. THEREFORE, BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. UNFORTUNATELY, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT AS THIS DEFECT COULD BE CAUSED BY MANUFACTURING OR IMPROPER HANDLING DUE TO THE OBSERVED DAMAGE TO THE PACKAGING. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EXPERIENCED BROKEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE CATHETER FROM ITS PACKAGING, THE NEEDLE BROKE. IMMEDIATE CONSEQUENCES: NO CONSEQUENCES. IMMEDIATE ACTIONS: TAKING ANOTHER CATHETER (REPEATED OPERATION SEVERAL TIMES).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS EXPERIENCED BROKEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN REMOVING THE CATHETER FROM ITS PACKAGING, THE NEEDLE BROKE. IMMEDIATE CONSEQUENCES: NO CONSEQUENCES. IMMEDIATE ACTIONS: TAKING ANOTHER CATHETER (REPEATED OPERATION SEVERAL TIMES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368933 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown