BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ IV CATHETER

    MDR report key: 17237788 · Received June 30, 2023

    Report

    Report Number
    1710034-2023-00756
    Event Type
    Malfunction
    Date Received
    June 30, 2023
    Date of Event
    June 9, 2023
    Report Date
    August 16, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 12-JUL-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED THREE PHOTOGRAPHS AND ONE SEALED 20G X 1.16IN. INSYTE AUTOGUARD UNIT FROM LOT NUMBER 3010271. AN INSPECTION OF THE PROVIDED PHOTOS SHOWS A UNIT THAT APPEARS SEALED WITH A DARK SPOT ON THE NEEDLE COVER. THE RETURNED UNIT CONFIRMS THAT THE UNIT WAS SEALED, AND IT SHOWS THAT THE SPOT IS A SMEAR OF DARK MATERIAL ON THE NEEDLE COVER, WHICH APPEARED TO BE TRANSFERRED TO THE INNER SURFACE OF THE TOP WEB PACKAGING. YOUR REPORTED ISSUE WAS CONFIRMED. MICROSCOPIC EVALUATION FOUND THE FOREIGN MATTER ON THE RETURNED UNIT HAD THE CHARACTERISTIC OF A DARK MATERIAL THAT COULD TRANSFER FROM THE NEEDLE COVER TO THE PACKAGING. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT. THE FOREIGN MATTER MAY HAVE BEEN INTRODUCED DURING PACKAGING/MANUFACTURING AS A RESULT OF ENVIRONMENTAL FACTORS, INCOMING MATERIAL, PERSONNEL, OR PROCESSING (E.G., PLASTIC TOTES OR MACHINE COMPONENTS WEAR AND TEAR). DURING MANUFACTURING, TO MITIGATE THE OCCURRENCE OF THESE DEFECTS: OPERATORS PERFORM CLEANING PER THE QUALITY PLAN AND GOOD MANUFACTURING PRACTICES AND GOWNING ARE FOLLOWED, AND ENVIRONMENTAL CONTROLS AND INSPECTIONS FOR FOREIGN MATTER ARE PERFORMED PER THE QUALITY CONTROL AND SAMPLING PLANS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PRODUCTION OPERATOR IN CHARGE OF PACKAGING HAS DETECTED 1 BD INSYTE AUTOGUARD 20 GA WITH BLACK STAINS INSIDE THE BLISTER AND ON THE MEDICAL DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ IV CATHETER EXPERIENCED FOREIGN MATTER, CONTAMINATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A PRODUCTION OPERATOR IN CHARGE OF PACKAGING HAS DETECTED 1 BD INSYTE AUTOGUARD 20 GA WITH BLACK STAINS INSIDE THE BLISTER AND ON THE MEDICAL DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422211 BD INSYTE¿ AUTOGUARD¿ IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 3010271 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown