BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12CC CONTROL SYRINGE FR/TR/RA W/RESERVOIR

    MDR report key: 13280659 · Received January 18, 2022

    Report

    Report Number
    0001625425-2022-00932
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    November 5, 2021
    Report Date
    February 14, 2022
    Manufacturer
    ARGON MEDICAL DEVICES
    Product Code
    IZI
    UDI-DI
    00886333207213
    PMA / PMN Number
    K911732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE IS UNAVAILABLE FOR EVALUATION. WITHOUT SUCH EVIDENT TO REVIEW, THE COMPLAINT CANNOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS PROVIDED IN THE FUTURE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DHR AND INSPECTION RECORDS COULD NOT BE CONDUCTED SINCE A LOT NUMBER WAS NOT PROVIDED. ONE OPENED SAMPLE WAS RETURNED FOR REVIEW. IMAGES OF THE REPORTED ISSUE WERE ALSO PROVIDED BY THE CUSTOMER. EVIDENCE OF A UNKNOWN SUBSTANCE WAS VISIBLE BOTH IN THE IMAGES PROVIDED AND ON THE RETURNED SAMPLE. EXAMINATION OF THE RETURNED SAMPLE FOUND A YELLOW UNKNOWN SUBSTANCE ALONG THE PLUNGER AND AROUND THE RIM OF THE PLUNGER COLLAR. IT WAS STATED THAT THE SYRINGE BLOCKAGE DISAPPEARED AFTER IT WAS CLEANED. THE SYRINGE WAS TESTED BY THE ANALYST AND THE SYRINGE FUNCTIONED AS DESIGNED WITH ONLY SLIGHT RESISTANCE FROM THE PRESENCE OF THE YELLOW UNKNOWN SUBSTANCE ALONG THE PLUNGER. THEREFORE, THIS COMPLAINT COULD NOT BE CONFIRMED FOR A MANUFACTURING ERROR. THE MOST PROBABLE CAUSE FOR THE EXPERIENCED RESISTANCE/BLOCKAGE WAS MOST LIKELY THE RESULT OF AN EVENT WITHIN THE USER ENVIRONMENT IN WHICH THE PLUNGER WAS EXPOSED TO THE YELLOW UNKNOWN SUBSTANCE AS IT WAS STATED THE RESISTANCE OCCURRED DURING THE PROCEDURE. SINCE THE REPORTED ISSUE WAS MOST LIKELY THE RESULT OF AN EVENT WITHIN THE USER ENVIRONMENT AND NOT A MANUFACTURING ERROR, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. ARGON WILL CONTINUE TO MONITOR FOR ISSUES OF THIS NATURE IN THE FUTURE.

    Description of Event or Problem · 0

    DURING PROCEDURE, A PHYSICIAN WAS UNABLE TO PUSH/PULL THE PLUNGER DUE TO HIGH RESISTANCE. THE PROCEDURE WAS COMPLETED BY USING AN ADDITIONALLY OPENED REPLACEMENT (193210). AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMK: THE SYRINGE TIP WAS BLOCKED BY SOMETHING, AND HIGH RESISTANCE TO PULL THE PLUNGER WAS CONFIRMED, BEFORE CLEANING OF THE SAMPLE. IT WAS DISAPPEARED, AFTER CLEANING OF THE SAMPLE.

    Description of Event or Problem · 0

    DURING PROCEDURE, A PHYSICIAN WAS UNABLE TO PUSH/PULL THE PLUNGER DUE TO HIGH RESISTANCE. THE PROCEDURE WAS COMPLETED BY USING AN ADDITIONALLY OPENED REPLACEMENT(193210). AS A RESULT OF THE RETURNED SAMPLE(S) REVIEW AT GMK: -THE SYRINGE TIP WAS BLOCKED BY SOMETHING, AND HIGH RESISTANCE TO PULL THE PLUNGER WAS CONFIRMED, BEFORE CLEANING OF THE SAMPLE. -IT WAS DISAPPEARED, AFTER CLEANING OF THE SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172442 12CC CONTROL SYRINGE FR/TR/RA W/RESERVOIR 12CC CONTROL SYRINGE IZI ARGON MEDICAL DEVICES 193210 UNK 00886333207213

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other