BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7459148 · Received April 25, 2018

    Report

    Report Number
    1710034-2018-00190
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    April 11, 2018
    Report Date
    May 21, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: DEVICE/BATCH HISTORY RECORD REVIEW WAS CONDUCTED AND DISCLOSED THE FOLLOWING: LOT 7220674; WAS BUILT AND PACKAGED ON AFA LINE 11 ON 14AUG2017 THROUGH 17AUG2017 FOR THE QUANTITY OF 330,010EA. REVIEW DISCLOSED THAT THERE WERE NO INDICATIONS OF THE ALLEGED DEFECTS AS THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. REVIEW OF THE DHR REVEALED ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SETUP AND IN-PROCESS SAMPLING PLANS. IN PROCESS SAMPLES FOR NEEDLE RETRACTION BY BUTTON ACTIVATION WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. SAP (QN) DATABASE REVIEW FINDINGS: SUBJECT CODES WERE AN S2 SEVERITY RANKING. REVIEW WAS CONDUCTED FOR THIS MDR-LEVEL A INVESTIGATION; AS A RESULT OF THE REVIEW THERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE ALLEGED DEFECTS STATED IN THE PIR 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. OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. CONFIRMATION OF THE DEFECTS STATED IN THE PIR COULD NOT BE IDENTIFIED OR CONFIRMED AND CAUSE COULD NOT BE DETERMINED, AS THE UNIT DESCRIBED IN THE PRODUCT INCIDENT REPORT WAS NOT RETURNED FOR EVALUATION AND TESTING. THEREFORE, THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR TO SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECTS STATED IN THE PIR. THE ROOT CAUSE OF THIS INCIDENT IS INDETERMINATE. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. 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.

    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¿ BC SHIELDED IV CATHETER THERE WAS ISSUE WITH NEEDLE RETRACTION FAILURE. IT WAS STATED ¿DURING POSITIONING AND FINDING OF A VENOUS ACCESS WITH THE DEVICE MARKED, BY PULLING OUT THE MANDREL AND PRESSING THE WHITE SAFETY BUTTON, THE LATTER DOES NOT ACTIVATE AND THE VENOUS ACCESS IS LOST, THE LENGTH OF THE DEVICE BEING TOO LONG MAKES IT VERY DIFFICULT TO INSERT THE CVP. THIS HAPPENED TO MORE OPERATORS WITH MORE PATIENTS.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299915 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7220674

    Patients

    Seq Age Sex Outcome Treatment
    1 Other