BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER 20GA 1.00IN (1.1 X 25 MM)

    MDR report key: 10354047 · Received August 1, 2020

    Report

    Report Number
    1710034-2020-00488
    Event Type
    Malfunction
    Date Received
    August 1, 2020
    Date of Event
    July 8, 2020
    Report Date
    August 27, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814337
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED AN UNUSED 20 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 9213348 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 NO PHYSICAL/MECHANICAL DAMAGE TO THE RETURNED UNIT. THE CATHETER TIP WAS INSPECTED AND FOUND TO BE WITHIN PRODUCTION SPECIFICATIONS. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS UNABLE TO VERIFY THE REPORTED DEFECT. SINCE NO DEFECTS WERE FOUND DURING EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20GA 1.00IN (1.1 X 25 MM) EXPERIENCED CATHETER TIP DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381433, BATCH NO: 9213348. CUSTOMER RESPONSE: THE INCIDENT OCCURRED WEDNESDAY, (B)(6) 2020. REPORTED ISSUE: DEFECTIVE THE IV CATHETER IS IRREGULAR AT THE TIP; TYPICALLY IT SHOULD BE SMOOTH AND UNIFORMED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20 GA 1.00 IN (1.1 X 25 MM) EXPERIENCED CATHETER TIP DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 381433, BATCH NO: 9213348. CUSTOMER RESPONSE: THE INCIDENT OCCURRED (B)(6) 2020. REPORTED ISSUE: DEFECTIVE THE IV CATHETER IS IRREGULAR AT THE TIP; TYPICALLY IT SHOULD BE SMOOTH AND UNIFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818172 BD INSYTE AUTOGUARD SHIELDED IV CATHETER 20GA 1.00IN (1.1 X 25 MM) INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381433 9213348 30382903814337

    Patients

    Seq Age Sex Outcome Treatment
    1 Other