BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8895806 · Received August 14, 2019

    Report

    Report Number
    1710034-2019-00888
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 25, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814115
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED A USED 24 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 9021578 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 A V-SHAPED CUT IN THE TUBING NEAR THE TIP THAT WAS INDICATIVE OF THE NEEDLE PIERCING THROUGH THE CATHETER. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. HOWEVER, SINCE THE UNIT APPEARED TO HAVE BEEN USED AND RETURNED OUTSIDE OF ITS ORIGINAL PACKAGING A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE THROUGH THE CATHETER OCCURRED DURING USE WITH A BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE PORTION OF INSYTE PROJECTING THROUGH PLASTIC CATHETER. RN DID NOT NOTICE ON INITIAL INSERTION, BUT COULD SEE UNDER SKIN THAT IT LOOKED ABNORMAL. REMOVED FROM PATIENT AND NOTED THE TIP OF THE CATHETER BENT TO SIDE AND NEEDLE TIP STRAIGHT. CONFIRMED THAT RN DID NOT SEPARATE NEEDLE FROM CATHETER PRIOR TO INSERTION."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE THROUGH THE CATHETER OCCURRED DURING USE WITH A BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "NEEDLE PORTION OF INSYTE PROJECTING THROUGH PLASTIC CATHETER. RN DID NOT NOTICE ON INITIAL INSERTION, BUT COULD SEE UNDER SKIN THAT IT LOOKED ABNORMAL. REMOVED FROM PATIENT AND NOTED THE TIP OF THE CATHETER BENT TO SIDE AND NEEDLE TIP STRAIGHT. CONFIRMED THAT RN DID NOT SEPARATE NEEDLE FROM CATHETER PRIOR TO INSERTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689279 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9021578 30382903814115

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA Other