BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 7566688 · Received June 4, 2018

    Report

    Report Number
    1710034-2018-00251
    Event Type
    Malfunction
    Date Received
    June 4, 2018
    Date of Event
    May 10, 2018
    Report Date
    July 3, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818235
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE/BATCH HISTORY RECORD REVIEW FINDINGS: 7237905: THE LOT NUMBER WAS BUILT ON AFA LINE 2, FROM AUGUST 30, 2017 THRU SEPTEMBER 6, 2017. REVIEW OF THE DHR REVEALED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WERE PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. THERE WAS ONE UNRELATED QN ((B)(4) -¿SHALLOW PLUGS¿) INITIATED; DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION WERE APPLIED ACCORDING TO THE QUALITY MANAGEMENT SYSTEM. 7242968: THE LOT NUMBER WAS MANUFACTURED ON AFA LINE 5 FROM SEPTEMBER 7, 2017 THRU SEPTEMBER 12, 2017. THE REVIEW OF THE DHR REVEALED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. 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 ONE USED 22GA CATHETER/ADAPTER ASSEMBLY. VISUAL/MICROSCOPIC EXAMINATION: DAMAGE ON THE OUTER THREAD OF THE ADAPTER WAS OBSERVED. THERE WERE NO HOLES, SPLITS, KINKS, BENDS OR WRINKLES IN THE CATHETER TUBING. FLUID TEST: THE FLUID TEST WAS PERFORMED BY CONNECTING A LUER LOCK SYRINGE FILLED WITH WATER/FOOD COLORING SOLUTION AND FLUSHING THE LIQUIDS THROUGH THE CATHETER-ADAPTER ASSEMBLY. THE CONNECTION WAS SECURE AND NO RESISTANCE WAS FELT. NO LEAKAGE WAS OBSERVED AT ANY OF THE COMPONENTS OF THE UNIT DURING FLUSHING. NO DAMAGE ON THE OUTER THREADS OF THE ADAPTER WAS OBSERVED. THE OBSERVED DAMAGE COULD HAVE HAPPEN ANYWHERE ON THE LINE WHERE A MACHINE PART CONTACTS THE ADAPTER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THERE WAS A "CRACK LIKE BURR" FOUND ON THE CATHETER OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER AFTER PLACEMENT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    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 #: 7237905. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31.  DEVICE MANUFACTURE DATE: 2017-08-25. MEDICAL DEVICE LOT #: 7242968 . MEDICAL DEVICE EXPIRATION DATE: 2020-08-31.  DEVICE MANUFACTURE DATE: 2017-08-30. 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 A "CRACK LIKE BURR" FOUND ON THE CATHETER OF A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER AFTER PLACEMENT. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409820 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10. 00382903818235

    Patients

    Seq Age Sex Outcome Treatment
    1 Other