BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 13545698 · Received February 16, 2022

    Report

    Report Number
    1710034-2022-00081
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    February 4, 2022
    Report Date
    February 24, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: 2 POTENTIAL LOTS NUMBERS WERE PROVIDED. D4: MEDICAL DEVICE LOT #: 1168755. D4: MEDICAL DEVICE EXPIRATION DATE: 2024-05-31. H4: DEVICE MANUFACTURE DATE: 2021-10-19. D4: MEDICAL DEVICE LOT #: 1172748. H4: DEVICE MANUFACTURE DATE: 2021-10-19. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE USED CATHETER ADAPTER ASSEMBLY AND FOUR PHOTOS. UPON INSPECTION OF THE RECEIVED UNIT AND THE PHOTOS, IT WAS OBSERVED THAT THERE WAS A HOLE IN THE ADAPTER. MICROSCOPIC INSPECTION OF THE ADAPTER REVEALED THE SIDES OF THE HOLE HAD SMOOTH SURFACES INDICATING THAT IT WAS MOST LIKELY A RESULT OF A SHORT SHOT (INCOMPLETELY FORMED ADAPTERS) DURING THE MOLDING PROCESS. THE DEFECT OF LEAKAGE WAS CONFIRMED AS A RESULT OF ADAPTER DEFECTIVE/DAMAGED DUE TO THE MOLDING PROCESS. PREVENTATIVE MAINTENANCE AND QUALITY INSPECTIONS ARE PERFORMED AT REGULAR INTERVALS TO MITIGATE THE RISK FROM THIS TYPE OF DEFECT. ALTHOUGH THE SPECIFIC LOT NUMBER WAS NOT KNOWN, THE DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THE POTENTIAL BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER, THE DEVICE EXPERIENCED A DAMAGED HUB/ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS IS A REPORT ABOUT BLOOD LEAKAGE WITH THE USE OF IAGBC. ACCORDING TO THE CUSTOMER'S REPORT, AFTER VENIPUNCTURE, THE HCP CONNECTED IAGBC TO A SYRINGE FOR BLOOD COLLECTION, AND THEN SAW BLOOD LEAKING BETWEEN THE CATHETER AND THE CATHETER HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER, THE DEVICE EXPERIENCED A DAMAGED HUB/ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THIS IS A REPORT ABOUT BLOOD LEAKAGE WITH THE USE OF IAGBC. ACCORDING TO THE CUSTOMER'S REPORT, AFTER VENIPUNCTURE, THE HCP CONNECTED IAGBC TO A SYRINGE FOR BLOOD COLLECTION, AND THEN SAW BLOOD LEAKING BETWEEN THE CATHETER AND THE CATHETER HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1304094 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown