BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 9812564 · Received March 10, 2020

    Report

    Report Number
    1710034-2020-00160
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 12, 2020
    Report Date
    April 29, 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
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. BD RECEIVED ONE RETRACTED UNIT, A NEEDLE COVER, AND OPENED PACKAGING. UPON INSPECTION OF THE RETURNED UNIT, THE NEEDLE IS RETRACTED INTO THE BARREL OF THE DEVICE WHICH INDICATES THAT NEEDLE RETRACTION DID OCCUR. THE UNIT WAS INSPECTED VISUALLY AND MICROSCOPICALLY FOR ANY DAMAGE TO THE NEEDLE HUB AND GRIP WHICH MAY HAVE CAUSE THE NEEDLE TO CATCH BEFORE COMPLETELY RETRACTING. NO DAMAGE WAS OBSERVED TO THE HUB OR GRIP OF THE DEVICE. THE UNIT WAS THEN PUSHED OUT OF THE RETRACTED POSITION. THE UNIT WAS FURTHER INSPECTED, AND THE BUTTON WAS PRESSED TO IMITATE RETRACTION. NO ISSUES WITH RETRACTION WERE PRESENT. THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE FAILURE STATED IN YOUR 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

    IT WAS REPORTED THAT BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE DID NOT RETRACT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382533 BATCH NO.: 9241822. IT WAS REPORTED THE NEEDLE DID NOT RETRACT. PER COMPLAINT FORM: I HAVE AN IV CATHETER THAT WHEN THE NURSE WENT TO ACTIVATE IT THE NEEDLE DID NOT RETRACT.

    Additional Manufacturer Narrative · 1

    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 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER NEEDLE DID NOT RETRACT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 382533, BATCH NO.: 9241822. IT WAS REPORTED THE NEEDLE DID NOT RETRACT. PER COMPLAINT FORM: I HAVE AN IV CATHETER THAT WHEN THE NURSE WENT TO ACTIVATE IT THE NEEDLE DID NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278403 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 382533 9241822 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other