BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 9597094 · Received January 16, 2020

    Report

    Report Number
    1710034-2020-00009
    Event Type
    Malfunction
    Date Received
    January 16, 2020
    Date of Event
    December 20, 2019
    Report Date
    February 19, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825333
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE REPRESENTATIVE SAMPLES AND PHOTOGRAPHS FOR EVALUATION. BD RECEIVED 79 REPRESENTATIVE UNITS FROM ITEM NUMBER 382533, LOT NUMBER 9081511. IN ADDITION, TWO PHOTOGRAPHS WERE ALSO SUBMITTED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNITS. UPON INSPECTION OF THE REPRESENTATIVE UNITS RECEIVED, THE UNITS WERE VISUALLY INSPECTED FOR A SEPTUM, ACTUATOR, CORRECT SEATING OF ACTUATOR/SEPTUM, IF ACTUATOR HAS BEEN ACTUATED, AND MACHINE CAUSED DAMAGE. A SAMPLING OF 45 UNITS WERE PUT THROUGH A ¿BLOOD ESCAPE¿ TEST WHERE ALL UNITS PASSED TESTING WITH NO LEAKAGE OBSERVED. THE DEFECT OF LEAKAGE AS REPORTED WAS NOT CONFIRMED BASED ON EVALUATION OF THE RETURNED UNITS. THE RETURNED REPRESENTATIVE UNITS PROVIDED FOR EVALUATION MET AND PERFORMED PER THE REQUIRED MANUFACTURING SPECIFICATIONS. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURES STATED IN THE REPORT. 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

    MATERIAL NO: 382533. BATCH NO: 9081511. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE CATHETERS HAD NO BLOOD CONTROL (BC) WHICH RESULTED IN EXPOSURE TO BLOOD. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 382533, BATCH NO: 9081511. IT WAS REPORTED THAT DURING USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THE CATHETERS HAD NO BLOOD CONTROL (BC) WHICH RESULTED IN EXPOSURE TO BLOOD. THIS OCCURRED ON 3 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IAGBC HAD NO BC IN THIS CATHETER. CLINICIANS WERE EXPOSED TO BLOOD 3 TIMES AND TOOK THE DEVICE TO NURSE WHO THEN CONTACTED ME. SHE SAVED THE 3 CATHETERS THAT WERE USED AND THREW OUT THE REST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62421 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 9081511 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other