BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 10932407 · Received December 2, 2020

    Report

    Report Number
    9610048-2020-00167
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 5, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-25 H6: INVESTIGATION SUMMARY BD RECEIVED A 20 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 0120897 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 INSYTE AUTOGUARD UNIT WAS CONNECTED TO AN EXTENDER. THE REPORTED DEFECT WAS CONFIRMED. HOWEVER, THE DEVICE APPEARED TO HAVE BEEN USED AND IT WAS REPORTED THAT THE DEVICE WAS REINTRODUCED TO THE CATHETER. THE MOVEMENT OF REINSERTING THE CATHETER CAN CREATE A SITUATION IN WHICH THE TIP OF THE CANNULA IS DISCONNECTED FROM THE TIP OF THE CATHETER AND WHEN REINTRODUCED THE BEVEL CUTS THE CATHETER CREATING THE OBSERVED CONDITION. THE ROOT CAUSE COULD NOT BE DETERMINED. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD PNK 20GA X 1.16IN BROKE OFF INSIDE THE PATIENT'S SKIN. LOCAL ANESTHESIA WAS USED AND IT WAS REMOVED BY A SURGEON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROFESSIONAL AFTER SUCCESSFULLY PUNCTURING IN THE FIRST ATTEMPT, SHE FLUSHED WITH SALINE SOLUTION THE CATHETER AND THE PATIENT QUESTIONED ABOUT PAIN. COLLABORATOR REMOVED THE CATHETER AND IDENTIFIED THAT A PART OF THE CATHETER HAD NOT COME OUT. SHE REPORTED THAT THERE WAS LITTLE RESISTANCE WHEN WITHDRAWING. LOCAL ANESTHESIA FOR REMOVAL OF THE CATHETER FRAGMENT. INFO ADD: IT WAS POSSIBLE TO REMOVE THE CATHETER FRAGMENT. LOCAL ANESTHESIA AND REMOVED BY THE SURGEON. IT WAS IN THE PATIENT'S DERMIS. WHAT IS THE PATIENT'S CURRENT STATE? STABLE, HOSPITAL DISCHARGE. ABOUT THE SAMPLES: ONLY THE CATHETER IT WAS KEPT, BUT THE FRAGMENT THAT WAS IN THE DERMIS WAS DISCARDED.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE 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 INSYTE AUTOGUARD PNK 20GA X 1.16IN BROKE OFF INSIDE THE PATIENT'S SKIN. LOCAL ANESTHESIA WAS USED AND IT WAS REMOVED BY A SURGEON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PROFESSIONAL AFTER SUCCESSFULLY PUNCTURING IN THE FIRST ATTEMPT, SHE FLUSHED WITH SALINE SOLUTION THE CATHETER AND THE PATIENT QUESTIONED ABOUT PAIN. COLLABORATOR REMOVED THE CATHETER AND IDENTIFIED THAT A PART OF THE CATHETER HAD NOT COME OUT. SHE REPORTED THAT THERE WAS LITTLE RESISTANCE WHEN WITHDRAWING. LOCAL ANESTHESIA FOR REMOVAL OF THE CATHETER FRAGMENT. INFO ADD: IT WAS POSSIBLE TO REMOVE THE CATHETER FRAGMENT. LOCAL ANESTHESIA AND REMOVED BY THE SURGEON. IT WAS IN THE PATIENT'S DERMIS. WHAT IS THE PATIENT'S CURRENT STATE? STABLE, HOSPITAL DISCHARGE. ABOUT THE SAMPLES: ONLY THE CATHETER IT WAS KEPT, BUT THE FRAGMENT THAT WAS IN THE DERMIS WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400853 INSYTE AUTOGUARD PNK 20GA X 1.16IN CATHETER FOZ BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 381834 0120897 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention