BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    US CATHENA 22GX1.00IN STRAIGHT BC

    MDR report key: 11794922 · Received May 7, 2021

    Report

    Report Number
    8041187-2021-00390
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 10, 2021
    Report Date
    August 24, 2021
    Product Code
    FOZ
    UDI-DI
    00382903868612
    PMA / PMN Number
    K201717
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE SAFETY MECHANISM WAS OBSERVED TO NOT BE ACTIVATED AND THERE IS BLOOD AT THE NEEDLE HUB FLASHBACK CHAMBER. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. AS NO SAMPLE WAS RETURNED FOR INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-07-02. INVESTIGATION SUMMARY: ONE PHOTO AND SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE SAFETY MECHANISM WAS OBSERVED TO NOT BE ACTIVATED AND BLOOD WAS OBSERVED AT THE NEEDLE HUB FLASHBACK CHAMBER. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND THE SAFETY MECHANISM WAS OBSERVED TO BE ACTIVATED. NO DENT WAS OBSERVED ON THE CANNULA AND NO DAMAGE WAS OBSERVED ON THE V-CLIP AND WASHER COMPONENTS. THE SAFETY MECHANISM OF THE SAMPLE WAS MANUALLY DEACTIVATED AND THEN RE-ACTIVATED. NO SAFETY ACTIVATION FAILURE WAS OBSERVED, AS THE TIP SHIELD WAS ABLE TO BE PULLED FORWARD TO COVER THE SHARP CANNULA TIP. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT US CATHENA 22GX1.00IN STRAIGHT BC HAD A SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 386861 BATCH NO.: 0023846 IT WAS REPORTED THE NEEDLE COVER DID NOT LATCH OVER THE NEEDLE POINT. PER EMAIL: I ALMOST HAD A NEEDLE STICK AFTER I PLACED THIS 22G IV AND THE NEEDLE COVER DID NOT LATCH OVER THE NEEDLE POINT. AT THE TIME, I HAD PLACED 5 IV'S IN ONE HOUR SO I'M NOT SURE IF IT'S SOMETHING I DID WRONG OR IT WAS A FAULTY PRODUCT. I TOOK A PIC OF THE PACKAGE AS WELL SO WE HAD THE LOT # JUST IN CASE. IF IT WAS A MISTAKE ON MY PART, I'M CONCERNED THAT IT COULD HAPPEN AGAIN. I TOLD DAYLIGHT SHIFT ABOUT IT BUT DIDN'T SEND THIS TO THE TEAM UNTIL I GOT AN ANSWER ABOUT WHAT YOU THINK THE CAUSE MAY HAVE BEEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT US CATHENA 22GX1.00IN STRAIGHT BC HAD A SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 386861, BATCH NO.: 0023846. IT WAS REPORTED THE NEEDLE COVER DID NOT LATCH OVER THE NEEDLE POINT. PER EMAIL: I ALMOST HAD A NEEDLE STICK AFTER I PLACED THIS 22G IV AND THE NEEDLE COVER DID NOT LATCH OVER THE NEEDLE POINT. AT THE TIME, I HAD PLACED 5 IV'S IN ONE HOUR SO I'M NOT SURE IF IT'S SOMETHING I DID WRONG OR IT WAS A FAULTY PRODUCT. I TOOK A PIC OF THE PACKAGE AS WELL SO WE HAD THE LOT # JUST IN CASE. IF IT WAS A MISTAKE ON MY PART, I'M CONCERNED THAT IT COULD HAPPEN AGAIN. I TOLD DAYLIGHT SHIFT ABOUT IT BUT DIDN'T SEND THIS TO THE TEAM UNTIL I GOT AN ANSWER ABOUT WHAT YOU THINK THE CAUSE MAY HAVE BEEN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT US CATHENA 22GX1.00IN STRAIGHT BC HAD A SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 386861, BATCH NO.: 0023846 . IT WAS REPORTED THE NEEDLE COVER DID NOT LATCH OVER THE NEEDLE POINT. PER EMAIL: I ALMOST HAD A NEEDLE STICK AFTER I PLACED THIS 22G IV AND THE NEEDLE COVER DID NOT LATCH OVER THE NEEDLE POINT. AT THE TIME, I HAD PLACED 5 IV'S IN ONE HOUR SO I'M NOT SURE IF IT'S SOMETHING I DID WRONG OR IT WAS A FAULTY PRODUCT. I TOOK A PIC OF THE PACKAGE AS WELL SO WE HAD THE LOT # JUST IN CASE. IF IT WAS A MISTAKE ON MY PART, I'M CONCERNED THAT IT COULD HAPPEN AGAIN. I TOLD DAYLIGHT SHIFT ABOUT IT BUT DIDN'T SEND THIS TO THE TEAM UNTIL I GOT AN ANSWER ABOUT WHAT YOU THINK THE CAUSE MAY HAVE BEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690207 US CATHENA 22GX1.00IN STRAIGHT BC CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ 386861 0023846 00382903868612

    Patients

    Seq Age Sex Outcome Treatment
    1