BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC WING PNK 20GA X 1.0IN

    MDR report key: 11371019 · Received February 24, 2021

    Report

    Report Number
    1710034-2021-00141
    Event Type
    Malfunction
    Date Received
    February 24, 2021
    Date of Event
    January 28, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT#: 0232514. H.6. INVESTIGATION: BD RECEIVED TWO 20 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNITS FROM LOT 0232514 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND OBSERVED THAT THE NEEDLES HAD FULLY RETRACTED. ALSO, THERE APPEARED TO BE DRIED MEDIA PRESENT OUTSIDE OF THE FLASHBACK CHAMBER AND ON THE BOTTOM OF THE VENT PLUG. THE VENT PLUG IS INTENDED TO ALLOW FOR FLASHBACK TO OCCUR BUT PREVENT FLUID FROM FLOWING OUT THE BACK OF THE DEVICE UNLESS LEFT IN THE VEIN FOR A PROLONGED PERIOD OF TIME. THE VISUAL INSPECTION ALSO REVEALED THAT A FLOW PATH WAS VISIBLE ALONG A SMALL PORTION OF THE OUTSIDE OF THE VENT PLUGS ON THE DEVICES. THIS COMBINATION OF BLOOD ON THE OUTSIDE OF THE VENT PLUG AND THE VISIBLE PATH THE BLOOD HAD TAKEN, WAS INDICATIVE OF A DAMAGED VENT PLUG. NEXT, MICROSCOPIC INSPECTION DETERMINED THAT THE VENT PLUG HAD AN UNEVEN SURFACE CONFIRMING DAMAGE TO THE VENT PLUG. BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. IT WAS DETERMINED THAT THIS WAS A MANUFACTURING DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOG BC WING PNK 20GA X 1.0IN HAD ISSUES WITH THE BLOOD CONTROL FEATURE ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382633 BATCH NO: UNKNOWN (PROVIDED 0232514) IT WAS REPORTED BLOOD RETURN ON A AUTOGUARD PIV. VERBATIM: PER CUSTOMER'S RESPONSE (B)(6) 2021 WHAT ANYONE HURT? NOT TO MY KNOWLEDGE DO YOU HAVE PATIENT IDENTIFIERS? NO. THE PIR STATED YOU HAVE A PHOTO, CAN YOU PLEASE E-MAIL THE PHOTO TO US? YES, BELOW.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOG BC WING PNK 20GA X 1.0IN HAD ISSUES WITH THE BLOOD CONTROL FEATURE ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382633, BATCH NO: UNKNOWN (PROVIDED 0232514). IT WAS REPORTED BLOOD RETURN ON A AUTOGUARD PIV. VERBATIM: PER CUSTOMER'S RESPONSE 02/02/2021. WHAT ANYONE HURT? NOT TO MY KNOWLEDGE. DO YOU HAVE PATIENT IDENTIFIERS? NO. THE PIR STATED YOU HAVE A PHOTO, CAN YOU PLEASE E-MAIL THE PHOTO TO US? YES, BELOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271307 INSYTE AUTOG BC WING PNK 20GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0232514 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1