BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC

    MDR report key: 20054799 · Received August 23, 2024

    Report

    Report Number
    1710034-2024-00930
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    April 19, 2024
    Report Date
    August 22, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR WAS GENERATED DUE TO INVESTIGATION FINDINGS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS AND SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE 22G X 1.0 INCH INSYTE AUTOGUARD BC DEVICE FROM LOT NUMBER 4012523 AND TWO PHOTOGRAPHS. THE PHOTOGRAPHS ONLY SHOWED THE SAME UNIT LABEL FROM TWO ANGLES AND DID NOT PROVIDE ANY INFORMATION OR EVIDENCE TO SUPPORT THE REPORTED EVENT. AFTER REMOVING THE NEEDLE COVER, IT WAS NOTED THAT THE NEEDLE HAD PIERCED THE CATHETER TUBING NEAR THE CATHETER TIP. THE CATHETER TIP WAS NOT OVER THE CANNULA AS THE NEEDLE WAS PROTRUDING THROUGH THE SIDE OF THE CATHETER. A MICROSCOPIC EXAMINATION OF THE NEEDLE TIP REVEALED NO DAMAGE OR DEFECTS. THE CATHETER WAS EASILY ABLE TO ADVANCE OFF THE NEEDLE. A NEEDLE SPEAR THROUGH MAY ORIGINATE DURING THE MANUFACTURING PROCESS DUE TO MISALIGNMENT OF THE SET TOGETHER STATION, BENT TUBING, OR AIR BLOW INCONSISTENCY. THERE IS A 100 PERCENT AUTOMATED VISION SYSTEM INSPECTION AND A SAMPLING PLAN IMPLEMENTED FOR TIP SPEAR AND LIE DISTANCE, WHICH MITIGATES THE OCCURRENCE OF THIS DEFECT. THE DAMAGE MAY ALSO OCCUR IN THE CLINICIAN SETTING DURING TIP ADHESION BREAK. AS THE DEVICE HAS BEEN OPENED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHETHER THE DAMAGE ORIGINATED DURING MANUFACTURING OR MANIPULATION OF THE DEVICE DURING PREPARATION FOR USE. THERE WERE NO DISTINGUISHING FEATURES WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THE OBSERVED DAMAGE WOULD LIKELY COMPLICATE THE NEEDLE PUNCTURE AND CATHETER THREADING DURING THE INSERTION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC INVESTIGATION FOUND THAT NEEDLE PIERCED THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STAFF ARE REPORTING THAT THE BD INSYTE AUTOGARD BC IV NEEDLES ARE CAUSING ISSUES AGAIN. THEY ARE REPORTING THAT THEY ARE NOT SHARP AS WELL AS WHEN THEY TRY TO ADVANCE THE SHEATH, IT DOES NOT GO AS EASILY AS IT SHOULD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699118 BD INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4012523 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown