BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM

    MDR report key: 10407114 · Received August 14, 2020

    Report

    Report Number
    1710034-2020-00507
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Date of Event
    July 21, 2020
    Report Date
    October 1, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED ONE HUNDRED AND TWENTY-SEVEN UNITS FROM REF. 381412, LOT 0010393. ONE HUNDRED AND TWENTY-SIX UNITS WERE RETURNED IN SEALED PACKAGES AND ONE UNIT WAS RETURNED IN AN OPEN PACKAGE THAT CONTAINED THE CATHETER ADAPTER ASSEMBLY ONLY. PER BD POLICY, SEVENTY-FIVE OF THE UNOPENED UNITS WERE RANDOMLY SELECTED TO BE USED AS A REPRESENTATIVE GROUP FOR INSPECTION IN ADDITION TO THE ONE OPENED SAMPLE. THROUGH VISUAL/MICROSCOPIC EXAMINATION, THE OPENED UNIT REVEALED A V-SHAPED CUT NEAR THE TIP OF THE CATHETER TUBING THAT IS CHARACTERISTIC OF THE NEEDLE TIP PIERCING THROUGH THE TUBING. THE SEALED UNITS WERE ALSO VISUALLY/MICROSCOPICALLY INSPECTED AND NONE DISPLAYED ANY EVIDENCE OF DAMAGE TO THE CATHETER TUBING. WHILE BD WAS NOT ABLE TO CONFIRM THE REPORTED DEFECT OF THE CATHETER SPLITTING, THE DEFECT OF NEEDLE THROUGH CATHETER WAS ABLE TO BE CONFIRMED IN THE ONE OPENED UNIT. THIS TYPE OF DEFECT CAN OCCUR DURING THE MANUFACTURING PROCESS OR IN THE CLINICAL SETTING. SINCE THE UNIT WAS RECEIVED OUT OF ITS ORIGINAL PACKAGING, BD COULD NOT DETERMINE A DEFINITE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM) HAD A SPLIT CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PLASTIC INSYTE THAT GOES INTO THE VEIN KEEPS SPLITTING. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: INJURIES OR ADVERSE EVENT: NO, MEDLINE REFERENCE: 200395891, ITEM: 381412, QUANTITY AFFECTED: 3 CASES, LOT NUMBER: 0010393, PO #: 4512655020, ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PLASTIC INSYTE THAT GOES INTO THE VEIN KEEPS SPLITTING. CUSTOMER DISPOSITION REQUEST: CREDIT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 24 GA 0.75 IN (0.7 X 19 MM) HAD A SPLIT CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PLASTIC INSYTE THAT GOES INTO THE VEIN KEEPS SPLITTING. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: INJURIES OR ADVERSE EVENT: NO. MEDLINE REFERENCE: (B)(4), ITEM: 381412, QUANTITY AFFECTED: 3 CASES, LOT NUMBER: 0010393, PO#: (B)(4), ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PLASTIC INSYTE THAT GOES INTO THE VEIN KEEPS SPLITTING. CUSTOMER DISPOSITION REQUEST: CREDIT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870401 BD INSYTE AUTOGUARD SHIELDED IV CATHETER 24GA 0.75IN (0.7 X 19 MM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381412 0010393 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other