BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7790468 · Received August 16, 2018

    Report

    Report Number
    1710034-2018-00562
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    July 31, 2018
    Report Date
    September 11, 2018
    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
    PA, 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. SAMPLES NOR PHOTOS WERE PROVIDED FOR EVALUATION OF THIS INCIDENT. DHR FOR THIS LOT WAS PREVIOUSLY REVIEWED FOR PR 436937-474549 CR; WHICH DISCLOSED THE FOLLOWING: LOT 8051797; WAS BUILT ON AFA LINE 11 FROM (B)(6) 2018 THRU (B)(6) 2018. ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SETUP AND IN-PROCESS SAMPLING PLANS. IN PROCESS SAMPLING WAS PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. SAP (QN) DATABASE REVIEW; WAS CONDUCTED FOR THIS INVESTIGATION WHICH DISCLOSED THAT THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE REPORTED DEFECT ASSOCIATED WITH THE LOT NUMBER PROVIDED FOR THIS INCIDENT AS NO QNS WERE INITIATED. ANALYSIS OF PEURA (END USER RISK ANALYSIS) DISCLOSED THAT DUE TO LOW OCCURRENCE AND LIMITED SEVERITY, CURRENT RISK IS ACCEPTABLE. AS UNITS NOR PHOTOS WERE NOT PROVIDED FOR OBSERVATION AND/OR TESTING OF THIS INCIDENT THEREFORE THE ALLEGED DEFECT WAS NOT IDENTIFIED OR CONFIRMED AND A ROOT CAUSE WAS NOT 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. PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS AND/OR PROCESS CONTROL TECHNICIANS TO ENSURE ANY GROSS PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER HAD A SPLIT CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A 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 HAD A SPLIT CATHETER. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628903 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8051797 30382903825333

    Patients

    Seq Age Sex Outcome Treatment
    1 Other