BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC

    MDR report key: 8660604 · Received May 31, 2019

    Report

    Report Number
    1710034-2019-00575
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 13, 2019
    Report Date
    July 2, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED A CATHETER-ADAPTER ASSEMBLY ALONG WITH A NEEDLE COVER WITHIN AN OPEN PACKAGE FROM LOT NUMBER 8200662. THROUGH THE VISUAL/MICROSCOPIC EVALUATION OF THE OPENED UNIT A WHITE CLEAR PARTICLE SPECK WAS OBSERVED ON THE CATHETER TUBING OF THE ASSEMBLY. THE REPORTED ISSUE WAS CONFIRMED. THE WHITE-CLEAR MATERIAL OBSERVED NEAR THE CATHETER TUBING WAS CONFIRMED TO BE NON-FOREIGN (PLUG SHAVINGS) WHICH RESULTED FROM MANUFACTURING DURING THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382533, BATCH NO: 8200662. HEALTH PROFESSIONAL REPORTING THAT OVER THE WEEKEND THEY FOUND A SMALL SHAVING ON THE TIP OF THE NEEDLE AFTER THE SHIELD WAS REMOVED. SAMPLE IS AVAILABLE, COULD PROVIDE PHOTOS. LOT # 8200662.

    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 THE 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382533 BATCH, NO: 8200662. HEALTH PROFESSIONAL REPORTING THAT OVER THE WEEKEND THEY FOUND A SMALL SHAVING ON THE TIP OF THE NEEDLE AFTER THE SHIELD WAS REMOVED. SAMPLE IS AVAILABLE, COULD PROVIDE PHOTOS. LOT # 8200662.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454505 20G X 1.00IN (1.1 X 25 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8200662 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other