BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD PNK 20GA X 1.16IN

    MDR report key: 9324585 · Received November 14, 2019

    Report

    Report Number
    1710034-2019-01226
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 9, 2019
    Report Date
    December 12, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814344
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CORRECTIONS ARE AS FOLLOWS: MEDICAL DEVICE TYPE: FOZ . PMA / 510(K)#: K952861.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A INSYTE AUTOGUARD PNK 20GA X 1.16IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT ON THE INSYTE CATHETER, SOME WOULD NOT FULLY RETRACT, LEAVING THE VERY TIP OF THE NEEDLE STICKING OUT.OTHER TIMES THE NEEDLE WOULD RETRACT SLOWLY."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9225164. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2019-08-13. MEDICAL DEVICE LOT #: 9224609. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2019-08-12. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A INSYTE AUTOGUARD PNK 20GA X 1.16IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT ON THE INSYTE CATHETER, SOME WOULD NOT FULLY RETRACT, LEAVING THE VERY TIP OF THE NEEDLE STICKING OUT. OTHER TIMES THE NEEDLE WOULD RETRACT SLOWLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114440 INSYTE AUTOGUARD PNK 20GA X 1.16IN INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903814344

    Patients

    Seq Age Sex Outcome Treatment
    1 Other