BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7201569 · Received January 17, 2018

    Report

    Report Number
    1710034-2017-00531
    Event Type
    Malfunction
    Date Received
    January 17, 2018
    Date of Event
    December 27, 2017
    Report Date
    February 16, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULTS: ONE SAMPLE UNIT WAS RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. UPON EXAMINATION, BLACK PARTICLES WERE OBSERVED ON THE CATHETER NEAR THE TIP. THE BLACK PARTICLES WERE IDENTIFIED AS RESIDUAL MATERIAL FROM THE MANUFACTURING PROCESS. IN ORDER TO REDUCE THE POTENTIAL FOR INTRODUCING FOREIGN MATTER, CLEANING IS PERFORMED EACH SHIFT AND GOWNING POLICIES ARE IMPLEMENTED. DHR REVIEW WAS PERFORMED ON THE LOT NUMBER 6112795. THE LOT NUMBER WAS BUILT ON (B)(4), FROM MAY 24, 2016 THRU MAY 27, 2016. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. IN PROCESS SAMPLES FOR FOREIGN/NON FOREIGN MATERIAL, PARTICULATE LOOSE OR EMBEDDED WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT CURRENT RISK IS ACCEPTABLE. OCCURRENCE AND SEVERITY RANKINGS HAVE NOT CHANGED. OBSERVATIONS AND TESTING: RECEIVED ONE USED IAG 20GA UNIT IN FROM THE LOT NUMBER 6112795. MICROSCOPIC EXAMINATION SHOWED BLACK FLECKS OF FOREIGN MATTER ON THE CATHETER TUBING NEAR THE TIP. THE FM MEASURED APPROXIMATELY .20 SQUARE MILLIMETERS AND 20 SQUARE MILLIMETERS. CONCLUSIONS: THE DEFECT AS STATED AS THE REPORTED CODE WAS CONFIRMED WITH THE RETURNED UNIT AS RELATED TO THE MANUFACTURING PROCESS. THE FM WAS IDENTIFIED AS RESIDUAL MATERIAL FROM THE MANUFACTURING PROCESS .IT IS POSSIBLE IT COULD BE SHAVINGS FROM TOOLING MIXED WITH GREASE AND OTHER FM. 5S CLEANING IS PERFORMED BY EACH SHIFT TO MINIMIZE THE POTENTIAL FOR INTRODUCING FOREIGN MATTER TO THE PRODUCT. POTENTIAL NONCONFORMANCE INCLUDES ANY VIOLATIONS OF THE GMPS INCLUDING (B)(4), WHICH DEFINES THE BD GOWNING POLICY. 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 BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER THERE WAS FOREIGN MATTER WAS ON THE NEEDLE TIP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42489 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 6112795

    Patients

    Seq Age Sex Outcome Treatment
    1 Other