BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7684486 · Received July 13, 2018

    Report

    Report Number
    1710034-2018-00396
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 19, 2018
    Report Date
    September 5, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURE: NO. INVESTIGATION SUMMARY: DHR REVIEW WAS CONDUCTED, WHICH DISCLOSED THE FOLLOWING: LOT 8081549; WAS BUILT AND PACKAGED ON AFA LINE 12 ON 22MAR2018 THOUGH 26MAR2018 FOR THE QUANTITY OF (B)(4). REVIEW DISCLOSED NO INDICATION OF THE ALLEGED DEFECT; THERE WERE NO QNS INITIATED DURING THE BUILD OF THIS LOT AND NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD THAT WOULD IMPACT UPON THE QUALITY OF THE CATHETER PRODUCT. ALL REQUIRED CHALLENGE SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND IN-PROCESS SAMPLING PLANS. IN PROCESS SAMPLES FOR NEEDLE RETRACTION BY BUTTON ACTIVATION WERE PERFORMED AT VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. SAP (QN) DATABASE REVIEW; WAS CONDUCTED FOR THIS INVESTIGATION WHICH DISCLOSED THAT THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE ALLEGED DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT. 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. UNITS WERE NOT PROVIDED FOR THIS INCIDENT, THEREFORE THE ALLEGED DEFECT OF NEEDLE RETRACTION FAILURE COULD NOT BE IDENTIFIED NOR CONFIRMED AND A ROOT CAUSE COULD NOT BE ESTABLISHED. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE IN A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WOULD NOT RETRACT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    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 THAT THE NEEDLE IN A BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WOULD NOT RETRACT. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528351 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8081549 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Other