BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9181970 · Received October 11, 2019

    Report

    Report Number
    1710034-2019-01101
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 28, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818112
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE UNUSED UNIT IN A SLIGHTLY OPENED PACKAGE FROM CATALOG NUMBER 381811, LOT NUMBER 7171632 WAS RECEIVED, AND BD WAS PROVIDED WITH A PHOTO OF THE DEFECT FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 7171632, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTO AND OBSERVED SIX INSYTE AUTOGUARD PACKAGES. THE PACKAGES WERE PARTIALLY PEELED OPEN AT ONE END. THE SEAL WIDTH AND SEAL TRANSFER WERE OBSERVED TO BE ACCEPTABLE BUT WITHOUT THE PHYSICAL SAMPLE THE ENGINEER COULD NOT DETERMINE THE EXACT MEASUREMENTS. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. THIS WAS A KNOWN ISSUE FOR THE MANUFACTURING FACILITY AND AN INVESTIGATION WAS PERFORMED. IT WAS DETERMINED THAT THERE WAS AN ISSUE WITH THE ADHESIVE ON THE PAPER'S PACKAGE. BD SUPPLIER OLIVER-TOLAS USES A STANDARD REINFORCED PAPER THAT IS COMMON TO MANY OTHER SUPPLIERS, BUT THE ADHESIVE TYPE AND APPLICATION IS SPECIFIC TO OLIVER-TOLAS. THERE IS SUFFICIENT EVIDENCE TO DEMONSTRATE THE MATERIAL OR ADHESIVE APPLICATION IS THE ROOT CAUSE. A NEW SUPPLIER HAS BEEN CHOSEN AND THE ADHESIVE WAS CHANGED. CAPA 48637 WAS OPENED TO INVESTIGATE THE PACKAGE SEAL INTEGRITY COMPLAINTS AND IMPLEMENT CORRECTIVE ACTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PACKAGE STEAL INTEGRITY OCCURRED BEFORE USE WITH A BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PRIMARY PACKAGING IS OPENED".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 PACKAGE STEAL INTEGRITY OCCURRED BEFORE USE WITH A BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PRIMARY PACKAGING IS OPENED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976855 BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7171632 00382903818112

    Patients

    Seq Age Sex Outcome Treatment
    1 Other