BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 9365384 · Received November 22, 2019

    Report

    Report Number
    1710034-2019-01251
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    October 21, 2019
    Report Date
    December 27, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS PROVIDED. BD RECEIVED A 20GA INSYTE AUTOGUARD UNIT WITHIN AN OPEN PACKAGE FROM LOT NUMBER 9052990. THE NEEDLE-BARREL ASSEMBLY WAS RECEIVED FULLY RETRACTED. THROUGH THE VISUAL MICROSCOPIC EVALUATION, A SPECK OF BLACK MATERIAL WAS FOUND ON THE TIP OF THE CATHETER. THE REPORTED ISSUE WAS CONFIRMED. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY POLYETHYLENE/ETHYL ACRYLATE COPOLYMER MIXED WITH SILICONE. POLYETHYLENE IS VENT PLUG MATERIAL AND THE SILICONE IS USED ON THE CATHETERS AS A LUBRICANT. THE FOREIGN MATTER IS UNLIKELY POLYETHYLENE/ETHYL ACRYLATE FOREIGN MATTER THAT WOULD HAVE COME FROM PLUG SHAVINGS. THE ORIGIN IS MOST LIKELY ENVIRONMENTAL. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE WHICH APPEARS TO ENVIRONMENTAL RELATED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE FOREIGN MATTER WAS DISCOVERED ON THE NEEDLE TIP WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: FM WAS ON THE NEEDLE TIP.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE FOREIGN MATTER WAS DISCOVERED ON THE NEEDLE TIP WITH A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FM WAS ON THE NEEDLE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1160928 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9052990

    Patients

    Seq Age Sex Outcome Treatment
    1 Other