BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 12538559 · Received September 28, 2021

    Report

    Report Number
    1710034-2021-00846
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 30, 2021
    Report Date
    October 6, 2021
    Product Code
    FOZ
    UDI-DI
    30382903826446
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD RECEIVED AN 18 GAUGE INSYTE AUTOGUARD BLOOD CONTROL IV CATHETER FROM LOT 1061862 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 UNIT AND OBSERVED THAT THE NEEDLE HAD PIERCED THROUGH THE CATHETER TUBING NEAR THE NOSE OF THE ADAPTER. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT CAUSED BY THE ASSEMBLY PROCESS. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION WAS ISSUED BY THE MANUFACTURING FACILITY TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER, THE DEVICE EXPERIENCED THE CATHETER SPLITTING/CRACKING/SHEARING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE CATHETER WAS SHREDDED BEFORE THEY OPENED THEM. PRODUCT ISSUE: ¿THE CATHETER IS SHREDDED BEFORE WE OPEN THEM¿.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 WHEN USING THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER, THE DEVICE EXPERIENCED THE CATHETER SPLITTING/CRACKING/SHEARING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THE CATHETER WAS SHREDDED BEFORE THEY OPENED THEM. PRODUCT ISSUE: ¿THE CATHETER IS SHREDDED BEFORE WE OPEN THEM.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436295 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ 382644 1061862 30382903826446

    Patients

    Seq Age Sex Outcome Treatment
    1