BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7530136 · Received May 21, 2018

    Report

    Report Number
    1710034-2018-00231
    Event Type
    Malfunction
    Date Received
    May 21, 2018
    Date of Event
    May 1, 2018
    Report Date
    August 24, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825349
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: LOT 7323650 WAS PROVIDED, YET IT IS NOT A LOT NUMBER FOR MATERIAL 382534. CORRECT LOT NUMBER 7223650. DEVICE/BATCH HISTORY RECORD REVIEW WAS PERFORMED ON THE LOT NUMBER: 7223650. THE PRODUCT WAS BUILT ON AFA LINE 11, FROM AUGUST 17, 2017 THRU AUGUST 21, 2017. 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. SETUP AND 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. QN / SAP DATABASE REVIEW FINDINGS: THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE DEFECT 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: RECEIVED TWO IAG /BC 20GA UNITS FROM THE LOT NUMBER 7223650. ONE UNIT WAS USED AND TAPED TO THE PAPER TOP WEB (UNIT LABEL). ONE WAS UNUSED AND IN A SEALED PACKAGE. VISUAL/MICROSCOPIC EXAMINATION: USED UNIT: THE NEEDLE WAS NOT RETRACTED, AND THE WHITE BUTTON WAS NOT DEPRESSED. OBSERVED THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE COMPONENTS (SPRING, NEEDLE HUB, GRIPS) OR EVIDENCE OF ADHESIVE ON THE BUTTON OR HUB. UNUSED UNIT: REMOVED FROM SEALED UNIT PACKAGE FOR EVALUATION. OBSERVED THERE WAS NO MECHANICAL/PHYSICAL DAMAGE TO ANY OF THE COMPONENTS (SPRING, NEEDLE HUB, GRIPS) OR EVIDENCE OF ADHESIVE ON THE BUTTON OR HUB. FUNCTIONAL TEST (NEEDLE RETRACTION) WAS PERFORMED: PERFORMED THE HUB TWIST TEST ON BOTH UNITS THEN DEPRESSED THE BUTTONS. THE RETRACTION WAS SUCCESSFUL, NO DELAYED REACTION WAS OBSERVED. CONCLUSIONS: THE DEFECT NEEDLE RETRACTION FAILURE, AS STATED IN THE DESCRIPTION OF THE COMPLAINT, WAS NOT CONFIRMED WITH THE RETURNED UNITS. THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE REPORTED DEFECT. THE DEFECT DESCRIBED IN THE INCIDENT REPORT COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED UNITS. THERE WAS NO DEFINITE PHYSICAL OR MECHANICAL EVIDENCE THAT CONFIRMED AND SUPPORTED MANUFACTURING PROCESS RELATED ISSUES FOR THE DEFECT OBSERVED IN THIS INCIDENT. A FORMAL CORRECTIVE ACTION WILL NOT BE INITIATED AT THIS TIME. A MANUFACTURING RELATED ROOT CAUSE COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RETRACTION FEATURE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAS HAD OFF AND ON ISSUES OF THE RETRACTION BUTTON STICKING DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    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.

    Additional Manufacturer Narrative · 1

    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: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETRACTION FEATURE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER HAS HAD OFF AND ON ISSUES OF THE RETRACTION BUTTON STICKING DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RETRACTION FEATURE OF THE BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER HAS HAD OFF AND ON ISSUES OF THE RETRACTION BUTTON STICKING DURING USE. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372667 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7223650 00382903825349

    Patients

    Seq Age Sex Outcome Treatment
    1 Other