BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18G X 1.16IN (1.3 X 30 MM) INSYTE AUTOGUARD

    MDR report key: 8967590 · Received September 5, 2019

    Report

    Report Number
    1710034-2019-00971
    Event Type
    Malfunction
    Date Received
    September 5, 2019
    Date of Event
    August 19, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814443
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: AN ADDITIONAL LOT NUMBER WAS ADDED TO THE COMPLAINT. D.4. MEDICAL DEVICE LOT #: 9071656 D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2022 H.4. DEVICE MANUFACTURE DATE: 1/31/2019 H.6. INVESTIGATION SUMMARY: RECEIVED TWO UNUSED IAG 18GA UNITS IN SEALED PACKAGES FROM MATERIAL NUMBER 381444; AS FOLLOWS: ONE UNIT FROM LOT NUMBER 9031625 (LABELED "KATY - KIT"). ONE UNIT FROM LOT NUMBER 9071656 (LABELED "KATY-SHELF"). A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. VISUAL/MICROSCOPIC EVALUATION: NO BENDS, CRIMPS, HOLES, KINKS, SPLITS, OR WRINKLES NOR THE CHARACTERISTIC V SHAPE OF A SPEAR THRU IN THE CATHETER TUBING OF THE RETURNED UNITS. TIP ADHESION: HOLDING THE CATHETER HUB, MANUALLY ROTATED THE CLEAR BARRELS 360 DEGREES, OBSERVED NO CANDY CANING AND THERE WAS NO STICKINESS FELT. CATHETER TIP GRADING: BOTH TIPS WERE GRADED 5, ACCEPTABLE. CONCLUSION: THE DEFECT CATHETER DEFECTIVE/DAMAGE WAS NOT IDENTIFIED OR CONFIRMED WITH THE RETURNED UNITS. THERE WAS NO PHYSICAL OR MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT. THE ROOT CAUSE WAS INDETERMINATE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE 18G X 1.16IN (1.3 X 30 MM) INSYTE AUTOGUARD HAS BEEN EXPERIENCING THREE OCCURRENCES OF DEFORMED CATHETERS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT IV CATHETER LOOKED LIKE IT HAD MELTED AND HAD DIFFICULTY TO SLIDE THE CATHETER OFF THE NEEDLE. IT WAS REPORTED TO ME ON 8/6. I THINK IT WAS SEVERAL DAYS PRIOR THAT THEY STARTED NOTICING THE ISSUE. VERBATIM: "THE IV CATHETER SEEMS TO HAVE MELTED A LITTLE BIT. IT IS HARD TO SLIDE THE CATHETER OFF THE NEEDLE EVEN AFTER LOOSENING." THESE ARE IN THE HOSPITAL'S CARDINAL VAG DELIVERY KITS. THEY HAVE LOOKED AT THEIR IVS OFF THE SHELF THAT ARE NOT IN THE CARDINAL KITS, AND THOSE SEEM TO BE JUST FINE.

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE 18G X 1.16 IN (1.3 X 30 MM) INSYTE AUTOGUARD HAS BEEN EXPERIENCING THREE OCCURRENCES OF DEFORMED CATHETERS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT IV CATHETER LOOKED LIKE IT HAD MELTED AND HAD DIFFICULTY TO SLIDE THE CATHETER OFF THE NEEDLE. IT WAS REPORTED TO ME ON 8/6. I THINK IT WAS SEVERAL DAYS PRIOR THAT THEY STARTED NOTICING THE ISSUE. VERBATIM: "THE IV CATHETER SEEMS TO HAVE MELTED A LITTLE BIT. IT IS HARD TO SLIDE THE CATHETER OFF THE NEEDLE EVEN AFTER LOOSENING." THESE ARE IN THE HOSPITAL'S CARDINAL VAG DELIVERY KITS. THEY HAVE LOOKED AT THEIR IVS OFF THE SHELF THAT ARE NOT IN THE CARDINAL KITS, AND THOSE SEEM TO BE JUST FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761511 18G X 1.16IN (1.3 X 30 MM) INSYTE AUTOGUARD INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 071656 30382903814443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other