BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN

    MDR report key: 12095869 · Received June 30, 2021

    Report

    Report Number
    1710034-2021-00541
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    May 6, 2021
    Report Date
    July 28, 2021
    Product Code
    FOZ
    UDI-DI
    00382903815333
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TWO RETRACTED UNITS AND TWO OPENED PACKAGES, ONE FROM LOT 0233025 AND ONE FROM LOT 1061874. DUE TO THE UNITS BEING LOOSE IN THE PACKAGE AND NOT ATTACHED TO ANY PARTICULAR PACKAGE, A LOT COULD NOT BE IDENTIFIED FOR THE TWO RETRACTED UNITS WITH CERTAINTY. A MICROSCOPIC INSPECTION OF THE CATHETER TUBING WAS PERFORMED ON BOTH UNITS AND A V SHAPE CUT WAS IDENTIFIED IN BOTH CATHETER TUBINGS- ONE UNIT NEAR THE TIP OF THE CATHETER AND THE OTHER NEAR THE MIDDLE OF THE CATHETER. THE V SHAPE IS INDICATIVE OF THE NEEDLE TIP PIERCING THROUGH THE CATHETER WALL; THEREFORE, THE DEFECT OF NEEDLE THROUGH CATHETER WAS CONFIRMED IN BOTH UNITS. THE UNIT WITH THE DAMAGE LOCATED APPROXIMATELY AT THE MIDDLE OF THE CATHETER TUBING WAS RETURNED WITH MEDIA INSIDE THE TUBING. IF THE SPEAR THROUGH HAD OCCURRED DURING MANUFACTURING, VENIPUNCTURE WOULD HAVE BEEN UNLIKELY AND FLASHBACK WOULD NOT HAVE OCCURRED SINCE THE THE DAMAGE WAS LOCATED BELOW THE NOTCH. THE PRESENCE AND LOCATION OF MEDIA INDICATES THAT THE DEFECT MOST LIKELY OCCURRED IN THE USER ENVIRONMENT. THE SECOND UNIT WAS RETURNED WITH NO MEDIA PRESENT AND WAS OBSERVED TO HAVE A SPEAR THROUGH LOCATED AT THE CATHETER TIP. CATHETER TIP SPEARS MAY ORIGINATE DURING MANUFACTURING, DURING TIP ADHESION BREAK BEFORE USE, OR WHILE PERFORMING VENIPUNCTURE BY MOVING THE CANNULA UP AND DOWN THE CATHETER TUBING. AS THE DEVICE HAD BEEN OPENED, IT COULD NOT BE DETERMINED WITH CERTAINTY WHERE THE DEFECT ORIGINATED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. THE PHOTO DISPLAYED THE ONLY LABEL OF A PACKAGE FROM MATERIAL #381533 LOT #1061874. UNFORTUNATELY, THE PHOTO PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE. ADDITIONAL INSPECTIONS OR INVESTIGATION INTO THE REPORTED DEFECT COULD NOT BE PERFORMED WITHOUT THE PHYSICAL SAMPLE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN NEEDLE WENT THROUGH THE CATHETER. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE NEEDLE AND IT WAS THROUGH THE CATHETER, THE OUTER CATHETER OF THE IV PUNCTURED THROUGH THE NEEDLE.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0233025, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: 2020-08-21. MEDICAL DEVICE LOT #: 1061874, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2021-03-02. 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 INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN NEEDLE WENT THROUGH THE CATHETER. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE NEEDLE AND IT WAS THROUGH THE CATHETER, THE OUTER CATHETER OF THE IV PUNCTURED THROUGH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988304 INSYTE AUTOGUARD WINGED PNK 20GA X 1.0IN INTRAVASCULAR CATHETER FOZ SEE H.10 00382903815333

    Patients

    Seq Age Sex Outcome Treatment
    1