BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 11780822 · Received May 5, 2021

    Report

    Report Number
    1710034-2021-00371
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 8, 2021
    Report Date
    December 16, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. DURING THE INSPECTION OF THE PHOTO, IT WAS OBSERVED THAT THERE WAS A CRACK IN THE BODY OF THE CATHETER ADAPTER RIGHT ABOVE THE PUSH TAB. THE REPORTED DEFECT WAS CONFIRMED. THIS TYPE OF DEFECT CAN OCCUR DURING MANUFACTURING BUT ALSO IN THE USER ENVIRONMENT. WITHOUT EXAMINING THE ACTUAL DEVICE, BD WAS UNABLE TO DETERMINE WHICH CAUSE WAS MORE LIKELY. PREVENTATIVE MAINTENANCE AND QUALITY INSPECTIONS ARE PERFORMED AT REGULAR INTERVALS TO MITIGATE THE RISK FROM THIS TYPE OF DEFECT. OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED UNIT AND ONE PHOTO. VISUAL INSPECTION REVEALED THAT THE BUTTON WAS STUCK IN THE PRESSED POSITION BUT THE UNIT HAD NOT RETRACTED, CONFIRMING YOUR REPORTED DEFECT. DURING FURTHER INSPECTION THE SAFETY MECHANISM UNINTENTIONALLY ACTIVATED, PREVENTING FURTHER OBSERVATIONS TO BE MADE. DESPITE THIS, THE DEFECT WAS DETERMINED TO MOST LIKELY BE RELATED TO THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-12-07. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE CATHETER ADAPTER ASSEMBLY, ONE MISCELLANEOUS BLOOD COLLECTION DEVICE, AND MISCELLANEOUS EXTENSION TUBING. ONE PHOTO WAS ALSO RECEIVED. DURING THE INSPECTION, IT WAS OBSERVED THAT THERE WAS A CRACK IN THE BODY OF THE CATHETER ADAPTER RIGHT ABOVE THE PUSH TAB. THE REPORTED DEFECT WAS CONFIRMED. THE OBSERVED DAMAGE IS UNLIKELY TO ORIGINATE DURING USE AS HIGH FORCES ARE REQUIRED TO CRACK THE ADAPTER; THEREFORE, THE DEFECT WAS DETERMINED TO BE MOST LIKELY RELATED TO THE MANUFACTURING PROCESS. THIS TYPE OF DEFECT CAN OCCUR DURING MANUFACTURING DUE TO MISALIGNMENT. PREVENTATIVE MAINTENANCE AND QUALITY INSPECTIONS ARE PERFORMED AT REGULAR INTERVALS TO MITIGATE THE RISK FROM THIS TYPE OF DEFECT. 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 1 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IN LOT 0275653 FAILED TO RETRACT THE NEEDLE, AND 1 CATHETER IN LOT 0212219 HAD A BROKEN HUB THAT CAUSED BLOOD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. NEEDLE CAN'T BE RETRACTED. 2. HUB BROKEN. WHEN THE CATHETER PLACED IN THE VESSEL, THE HUB WAS BROKEN AND BLOOD FLOWED OUT, CAUSED THE PATIENT'S BLOOD OUT A LOT OF AMOUNT. AFTER THE REMOVAL, THE SECOND INTRAVENOUS INDWELLING NEEDLE HAD TO BE REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IN LOT 0275653 FAILED TO RETRACT THE NEEDLE, AND 1 CATHETER IN LOT 0212219 HAD A BROKEN HUB THAT CAUSED BLOOD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " 1. NEEDLE CAN'T BE RETRACTED. 2. HUB BROKEN. WHEN THE CATHETER PLACED IN THE VESSEL, THE HUB WAS BROKEN AND BLOOD FLOWED OUT, CAUSED THE PATIENT'S BLOOD OUT A LOT OF AMOUNT. AFTER THE REMOVAL, THE SECOND INTRAVENOUS INDWELLING NEEDLE HAD TO BE REPLACED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0275653, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0212219, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. 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 1 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER IN LOT 0275653 FAILED TO RETRACT THE NEEDLE, AND 1 CATHETER IN LOT 0212219 HAD A BROKEN HUB THAT CAUSED BLOOD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " NEEDLE CAN'T BE RETRACTED. HUB BROKEN. WHEN THE CATHETER PLACED IN THE VESSEL, THE HUB WAS BROKEN AND BLOOD FLOWED OUT, CAUSED THE PATIENT'S BLOOD OUT A LOT OF AMOUNT. AFTER THE REMOVAL, THE SECOND INTRAVENOUS INDWELLING NEEDLE HAD TO BE REPLACED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677641 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 SEE SECTION H.10. 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown