BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 7327473 · Received March 9, 2018

    Report

    Report Number
    1710034-2018-00113
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Date of Event
    February 9, 2018
    Report Date
    March 14, 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 · 0

    (B)(4). A TOTAL OF (B)(4) WERE BUILT ON AFA LINE 11, FROM (B)(6) 2017 THROUGH (B)(6) 2017. REVIEW OF THE DHR REVEALED 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¿ AND ¿PARTICULATE LOOSE-EMBEDDED¿ WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. (B)(4). A TOTAL OF (B)(4) UNITS WERE BUILT ON AFA LINE 11, FROM (B)(6) 2017 THROUGH (B)(6) 2017. REVIEW OF THE DHR REVEALED 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¿ AND ¿PARTICULATE LOOSE-EMBEDDED¿ WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. OBSERVATIONS AND TESTING: RECEIVED AN UNUSED 22GA CATHETER/ADAPTER ASSEMBLY WITH NO PACKAGING MATERIAL. A PIECE OF WHITE/CLEAR MATTER WAS PRESENT ON THE CATHETER TIP OF THE UNIT RECEIVED AND WAS IDENTIFIED TO BE NON-FOREIGN PLUG SHAVINGS MATERIAL. NO DAMAGE WAS OBSERVED ON THE TIP OF THE CATHETER AND WAS ACCEPTABLE PER SPECIFICATIONS. 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. BASED ON THE VISUAL EVALUATION PERFORMED IT WAS OBSERVED A PIECE OF WHITE/CLEAR MATTER WAS PRESENT ON THE CATHETER TIP OF THE UNIT RECEIVED AND WAS IDENTIFIED TO BE NON-FOREIGN PLUG SHAVINGS MATERIAL. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO: THE CUSTOMER¿S EXPERIENCE WAS NOT REPRODUCED IN THE LABORATORY. ROOT CAUSE WAS DETERMINED TO BE MANUFACTURING. THE MATTER OBSERVED ON THE CATHETER TUBING WAS CONFIRMED TO BE NON-FOREIGN (PLUG SHAVINGS MATERIAL) AND TO HAVE RESULTED FROM MANUFACTURING DURING THE ASSEMBLY PROCESS. 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

    TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS:  MEDICAL DEVICE LOT #: 7198573, MEDICAL DEVICE EXPIRATION DATE: 2020-06-30, DEVICE MANUFACTURE DATE: 2017-07-17. MEDICAL DEVICE LOT #: 7110785, MEDICAL DEVICE EXPIRATION DATE: 2020-03-31,  DEVICE MANUFACTURE DATE: 2017-04-20. 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 THERE WAS FOREIGN MATTER WAS FOUND ON THE CATHETER TIP OF A BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171866 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other