BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 12215632 · Received July 22, 2021

    Report

    Report Number
    1710034-2021-00607
    Event Type
    Malfunction
    Date Received
    July 22, 2021
    Date of Event
    June 18, 2021
    Report Date
    August 16, 2021
    Product Code
    FOZ
    UDI-DI
    00382903818129
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD RECEIVED A 24 GAUGE INSYTE AUTOGUARD UNIT FROM LOT 0191501 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUT QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED THAT THE NOSE OF THE DEVICE WAS DAMAGED. NEXT, A WATER/AIR LEAK TEST WAS PERFORMED TO DETERMINE IF THE DAMAGE WAS JUST COSMETIC OR IF IT IMPACTED THE FUNCTION OF THE DEVICE. DURING TESTING, NO LEAKAGE WAS OBSERVED COMING FROM THE UNIT AND IT WAS DETERMINED THAT THE DAMAGE WAS JUST COSMETIC. THEREFORE, BASED OFF THE VISUAL INSPECTION AND TESTING THE ENGINEER WAS ABLE TO VERIFY THAT THE UNIT WAS DAMAGED. DAMAGE TO THE NOSE OF THE ADAPTER MAY OCCUR DUE TO A MISALIGNMENT BETWEEN THE MANUFACTURING EQUIPMENT AND THE ADAPTER OR IMPROPER GRIPPER SETTINGS DURING THE MANUFACTURING PROCESS. THE APPEARANCE AND LOCATION OF THE DAMAGE INDICATED THAT THE DEFECT WAS MOST LIKELY DUE TO CONTACT BETWEEN THE ADAPTER NOSE AND A PALLET. CONTACT BETWEEN THE ADAPTER NOSE AND A PALLET MOST COMMONLY OCCURRED DUE TO MISALIGNMENT OF THE ASSEMBLY EQUIPMENT. THE MANUFACTURING FACILITY HAS BEEN NOTIFIED OF THIS INCIDENT AND THE FINDINGS. A NOTIFICATION HAS BEEN ISSUED BY THE MANUFACTURING FACILITY TO ALL PRODUCTION STAFF TO RAISE AWARENESS OF THIS ISSUE AND PREVENT RECURRENCE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXHIBITED A DAMAGED ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ACCORDING TO THE CUSTOMER'S REPORT, THE HCP CONFIRMED BEFORE USE THAT THE CATHETER HUB WAS DAMAGED."

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER EXHIBITED A DAMAGED ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ACCORDING TO THE CUSTOMER'S REPORT, THE HCP CONFIRMED BEFORE USE THAT THE CATHETER HUB WAS DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107185 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ 381812 0191501 00382903818129

    Patients

    Seq Age Sex Outcome Treatment
    1