BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿

    MDR report key: 8184650 · Received December 20, 2018

    Report

    Report Number
    1710034-2018-00914
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 15, 2018
    Report Date
    January 18, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815341
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE 20GA IAG NEEDLE-BARREL ASSEMBLY WITHIN A MISCELLANEOUS CONTAINER ALONG WITH AN EMPTY-OPEN PACKAGE FROM LOT NUMBER 8151944. THE NEEDLE WAS RECEIVED FULLY RETRACTED INSIDE THE SAFETY BARREL. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE WITH LOT #6119819, REGARDING ITEM #381854. DHR REVIEW DISCLOSES A TOTAL OF (B)(4) UNITS WERE MANUFACTURED ON AFA LINE 7 FROM 4JUN18 THROUGH 7JUN18. PACKAGED ON PKG LINE 10 FROM 11JUN18 THROUGH 12JUN18. NO QUALITY NOTIFICATIONS WERE INITIATED DURING PRODUCTION. ALL CHALLENGE, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED ACCORDING TO THE QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. INVESTIGATION CONCLUSION: THE NEEDLE WAS PUSHED TO THE OUT POSITION AND THEN THE WHITE BUTTON WAS DEPRESSED. ALTHOUGH THE NEEDLE RETRACTED, RETRACTION WAS SLOW. UPON FURTHER EXAMINATION IT WAS DETECTED THE SPRING HAD CAUGHT UP INTO A PROTRUDING PIECE OF PLASTIC OBSERVED ON THE HUB OF THE ASSEMBLY. THE UNIT WAS DISASSEMBLED AND THE DAMAGE ON THE HUB WAS CONFIRMED. ROOT CAUSE DESCRIPTION: ALTHOUGH A DEFINITE SOURCE THAT CAUSED THE DAMAGE OBSERVED ON THE HUB (WHICH SLOWED RETRACTION) COULD NOT BE DETERMINED, THE FAILURE WAS MANUFACTURED RELATED AND IT WAS PRODUCED EITHER DUE TO A MOLDING DEFECT OR DURING THE ASSEMBLY PROCESS OF THE UNIT. RATIONALE: A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED MONTHLY. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ THERE WAS AN ISSUE WITH UPON RETRACTION OF THE NEEDLE IT DID NOT FULLY RETRACT.

    Additional Manufacturer Narrative · 1

    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 WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ THERE WAS AN ISSUE WITH UPON RETRACTION OF THE NEEDLE IT DID NOT FULLY RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024684 BD INSYTE¿ AUTOGUARD¿ INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8151944 30382903815341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other