BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC

    MDR report key: 8969593 · Received September 6, 2019

    Report

    Report Number
    1710034-2019-00973
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 2, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825128
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED A 24GA IAG BC UNIT ALONG WITH 2 PIECES OF TOP WEB (PACKAGING) FROM LOT NUMBER 9130559. THE UNIT CONSISTED OF A FULLY RETRACTED NEEDLE-BARREL ASSEMBLY AND A NEEDLE COVER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. VISUAL EVALUATION: THE UNIT WAS RECEIVED WITH THE NEEDLE FULLY RETRACTED INSIDE THE SAFETY BARREL. THE SAFETY BARREL REVEALED DAMAGE (CRACKS, BREAKAGE) AT ITS BOTTOM. THE NEEDLE-HUB-SPRING ASSEMBLY DID NOT REVEAL ANY PHYSICAL MECHANICAL DAMAGE. FUNCTIONAL: THE NEEDLE WAS PUSHED INTO THE OUT POSITION. THEN THE WHITE BUTTON WAS PRESSED, AND THE NEEDLE SUCCESSFULLY RETRACTED INSIDE THE SAFETY BARREL. CONCLUSION: INDETERMINATE: ALTHOUGH THE DEFECTS STATED ON THE EVENT DESCRIPTION COULD NOT BE REPLICATED IN THE LABORATORY, THE DAMAGE FOUND ON THE BARREL COULD PLAY A CONTRIBUTIVE FACTOR FOR RETRACTION FAILURE AND THEREFORE STICK INJURY. THE SOURCE THAT CAUSED THE DAMAGE ON THE BARREL IS UNKNOWN AND COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE STICK INJURY OCCURRED WITH A 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE NEEDLE NEVER RETRACTED CAUSING A NEEDLE STICK TO THE USER ON THE PALM OF THE HAND. PER EMAIL: I HAVE THE IV CATHETER THAT WAS USED ALONG WITH THE LOT NUMBER- 9130559. EMPLOYEE WAS STUCK BY INSYLE IV CATHETER NEEDLE AFTER AN UNSUCCESSFUL INSERTION OF THE IV. THE NEEDLE OF THE IV NEVER RETRACTED AND STUCK EMPLOYEE IN LEFT PALM OF HAND. THE INJURED EMPLOYEE WAS FOLLOWED BY EMPLOYEE HEALTH. THE POST-EXPOSURE PROCESS INVOLVES A MEDICAL EXAM, AN INJURY INVESTIGATION, POST-EXPOSURE LABS ANALYSIS AND POST-EXPOSURE PROPHYLACTIC MEDICATIONS IF WARRANTED. THE EMPLOYEE WILL FOLLOWED UP WITH EMPLOYEE HEALTH AS NEEDED."

    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 STICK INJURY OCCURRED WITH A 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE NEEDLE NEVER RETRACTED CAUSING A NEEDLE STICK TO THE USER ON THE PALM OF THE HAND. PER EMAIL: I HAVE THE IV CATHETER THAT WAS USED ALONG WITH THE LOT NUMBER- 9130559. EMPLOYEE WAS STUCK BY INSYLE IV CATHETER NEEDLE AFTER AN UNSUCCESSFUL INSERTION OF THE IV. THE NEEDLE OF THE IV NEVER RETRACTED AND STUCK EMPLOYEE IN LEFT PALM OF HAND. THE INJURED EMPLOYEE WAS FOLLOWED BY EMPLOYEE HEALTH. THE POST-EXPOSURE PROCESS INVOLVES A MEDICAL EXAM, AN INJURY INVESTIGATION, POST-EXPOSURE LABS ANALYSIS AND POST-EXPOSURE PROPHYLACTIC MEDICATIONS IF WARRANTED. THE EMPLOYEE WILL FOLLOWED UP WITH EMPLOYEE HEALTH AS NEEDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764268 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9130559 30382903825128

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention