BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 8529049 · Received April 18, 2019

    Report

    Report Number
    1710034-2019-00432
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    April 3, 2019
    Report Date
    May 22, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825449
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: REVIEW OF DHR REVEALED ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. REVIEW DISCLOSED NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED IN THE PIR. RECEIVED TWO UNUSED, IAG BC 18 GA RETRACTED NEEDLE/BARREL ASSEMBLIES FROM CATALOG NUMBER 382544; LOT NUMBER 8250979. VISUAL/MICROSCOPIC EVALUATION: BOTH RETURNED NEEDLE/BARREL ASSEMBLIES WERE RETRACTED. THE SPRING DISPENSE NOZZLES ADVANCE, AND FOR A PRESET AMOUNT OF TIME, DISPENSE SILICONE GREASE INTO THE GREASE HOLES ON THE GRIPS TO DAMPEN SPRING ACTION. THE DEFECT FOREIGN MATTER WAS NOT CONFIRMED OR IDENTIFIED WITH THE RETURNED UNITS. DURING THE MANUFACTURING PROCESS THE GEL DISPENSING NOZZLES ADVANCE, AND FOR A PRESET AMOUNT OF TIME, DISPENSE SILICONE GREASE INTO THE GREASE HOLES ON THE GRIPS TO DAMPEN SPRING ACTION. ONCE THE NEEDLE IS RETRACTED; WE ARE UNABLE TO DETERMINE THE AMOUNT OF SILICONE GREASE THAT WAS DISPENSED ON TO THE SPRING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN LUBRICANT FOUND IN THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS' SPRING CHANNELS BEFORE USE, COVERING THE "ENTIRE LENGTH" OF THE SPRING CHANNEL AS WELL AS WHERE THE TIP OF THE NEEDLE RETRACTS. LOT #' 8250979 AND AN UNKNOWN LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE 1 OF 2 RELATED INCIDENTS OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE STAFF CALLED ATTENTION TO THE LUBRICANT IN THE SPRING CHANNEL. IN MANY OF THE CATHETERS THE LUBE IS PRESENT THE ENTIRE LENGTH OF THE CHANNEL AND RIGHT AT THE TIP WHERE THE NEEDLE RETRACTS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 THAT THERE WAS FOREIGN LUBRICANT FOUND IN THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS' SPRING CHANNELS BEFORE USE, COVERING THE "ENTIRE LENGTH" OF THE SPRING CHANNEL AS WELL AS WHERE THE TIP OF THE NEEDLE RETRACTS. LOT #' 8250979 AND AN UNKNOWN LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE 1 OF 2 RELATED INCIDENTS OF THIS EVENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE STAFF CALLED ATTENTION TO THE LUBRICANT IN THE SPRING CHANNEL. IN MANY OF THE CATHETERS THE LUBE IS PRESENT THE ENTIRE LENGTH OF THE CHANNEL AND RIGHT AT THE TIP WHERE THE NEEDLE RETRACTS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319265 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8250979 30382903825449

    Patients

    Seq Age Sex Outcome Treatment
    1 Other