BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8351493 · Received February 19, 2019

    Report

    Report Number
    1710034-2019-00187
    Event Type
    Malfunction
    Date Received
    February 19, 2019
    Date of Event
    February 1, 2019
    Report Date
    April 2, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814672
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING DHR REVIEW: ALL CHALLENGE, SET-UP AND IN PROCESS INSPECTIONS WERE PERFORMED PER CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. NO QNS WERE INITIATED DURING PRODUCTION. RECEIVED A TOTAL OF 3 UNITS AS FOLLOWS: UNIT 1 ¿ A FULLY RETRACTED NEEDLE-BARREL ASSEMBLY AND A CATHETER-ADAPTER ASSEMBLY WITHIN AN OPEN PACKAGE FROM LOT: 8127892 UNIT 2 ¿ A FULLY RETRACTED NEEDLE-BARREL ASSEMBLY AND A CATHETER-ADAPTER ASSEMBLY WITHIN AN OPEN PACKAGE FROM LOT: 8212900. UNIT 3 ¿ A FULLY RETRACTED NEEDLE-BARREL ASSEMBLY WITHIN AN OPEN PACKAGE FROM LOT NUMBER: 8212900. VISUAL EXAMINATION: THE CATHETER TIPS WERE ACCEPTABLE PER SPECIFICATIONS AND NO EVIDENT DAMAGE WAS FOUND ON THE CATHETER TUBING. THE NEEDLES WERE PUSHED INTO THE OUT POSITION AND THE NEEDLE TIPS WERE ACCEPTABLE PER SPECIFICATIONS AND NO DAMAGE WAS FOUND ON THE CANNULA. THE NEEDLES SUCCESSFULLY RETRACTED UPON PRESSING THE WHITE BUTTON. NO PHYSICAL-MECHANICAL DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE UNITS RECEIVED AND NO MANUFACTURING RELATED ISSUES THAT WOULD TRIGGER THE FAILURE EXPERIENCED BY THE CUSTOMER WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS' HAD NEEDLES THAT WOULDN'T RETRACT AND THEIR HUBS WOULDN'T THREAD DURING USE. LOT #: 8212900 WAS REPORTED TO HAVE HAD 2 OCCURRENCES OF THIS EVENT AND LOT#: 8127892 WAS REPORTED TO HAVE HAD 1 OCCURRENCE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8212900. MEDICAL DEVICE EXPIRATION DATE: 2021-07-31. DEVICE MANUFACTURE DATE: 2018-07-31. MEDICAL DEVICE LOT #: 8127892. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2018-05-07. 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 3 OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETERS' HAD NEEDLES THAT WOULDN'T RETRACT AND THEIR HUBS WOULDN'T THREAD DURING USE. LOT # 8212900 WAS REPORTED TO HAVE HAD 2 OCCURRENCES OF THIS EVENT, AND LOT# 8127892 WAS REPORTED TO HAVE HAD 1 OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143086 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE SECTION H.10. 30382903814672

    Patients

    Seq Age Sex Outcome Treatment
    1 Other