BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC BLU 22GA X 1.0IN

    MDR report key: 11276833 · Received February 3, 2021

    Report

    Report Number
    1710034-2021-00083
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    November 13, 2020
    Report Date
    March 23, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2020-12-07 H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED FOURTEEN UNOPENED REPRESENTATIVE UNITS AND ONE OPENED UNIT WITHOUT THE CATHETER ADAPTER ASSEMBLY. IN ADDITION, FIVE PHOTOS WERE ALSO RECEIVED. THE UNITS WERE TESTED FOR LEAKAGE BEYOND THE SEPTUM AND CATHETER ADAPTER LEAKAGE. LEAKAGE WAS NOT OBSERVED DURING EITHER TEST. AS THE OPENED UNIT WAS NOT RETURNED WITH A CATHETER ADAPTER ASSEMBLY IT CANNOT BE TESTED FOR CATHETER ADAPTER LEAKAGE OR LEAKAGE BEYOND THE SEPTUM. ALL FIFTEEN NEEDLE ASSEMBLIES RECEIVED FROM THE CUSTOMER WERE TESTED FOR LEAKAGE BEYOND THE POROUS PLUG AND NO LEAKAGE WAS OBSERVED. THE DEFECT OF LEAKAGE COULD NOT BE CONFIRMED IN THE REPRESENTATIVE UNITS, ADDITIONALLY THE RETRACTED UNIT WAS NOT FOUND TO LEAK BEYOND THE PLUG. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN YOUR REPORT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOG BC BLU 22GA X 1.0IN HAD BLOOD CONTROL ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523 BATCH NO: 0252150. IT WAS REPORTED VIA DISCOVERED PRODUCT DEFECT REPORTING FORMS: CUSTOMER(S) REPORTED MULTIPLE BLOOD CONTROL/LEAK ISSUES.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN.(B)(6) HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INSYTE AUTOG BC BLU 22GA X 1.0IN HAD BLOOD CONTROL ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 382523, BATCH NO: 0252150. IT WAS REPORTED VIA DISCOVERED PRODUCT DEFECT REPORTING FORMS: CUSTOMER(S) REPORTED MULTIPLE BLOOD CONTROL/LEAK ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167855 INSYTE AUTOG BC BLU 22GA X 1.0IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382523 0252150 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1