BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 6850206 · Received September 7, 2017

    Report

    Report Number
    1710034-2017-00181
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 16, 2017
    Report Date
    September 23, 2017
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: THE CORRECTIVE ACTION STATEMENT IS APPROVED/AUTHORIZED AND FINAL REVIEW OF THE COMPLAINT WILL BE CONDUCTED BY DESIGNATED COMPLAINT HANDLING UNIT. DEVICE/BATCH HISTORY RECORD REVIEW: PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATION IN ACCORDANCE WITH THE SET-UP AND 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, LOOSE OR EMBEDDED WERE PERFORMED ON VARIOUS STAGES THROUGHOUT THE PROCESS, ALL THE INSPECTIONS PASSED PER SPECIFICATIONS. NO SIGNIFICANT DISCOVERIES WERE FOUND. VISUAL ANALYSIS: OBSERVATIONS AND TESTING: RECEIVED ONE UNUSED IAG 24GA UNIT WITHOUT PACKAGING ALONG WITH (B)(4) UNITS WITHIN SEALED PACKAGES FROM THE LOT NUMBER 7211747. VISUAL/MICROSCOPIC EXAMINATION: 100% VISUAL INSPECTION WAS PERFORMED. NON-PACKAGED UNIT: DURING MICROSCOPIC EXAMINATION IT WAS OBSERVED A BLACK-BROWN PARTICLE ON THE CATHETER TUBING NEAR THE CATHETER TIP. THE FM WAS ABOUT .08 SQUARE MM PER TAPPI CHART. USING A COTTON SWAB THE PARTICLES WAS REMOVED CONFIRMING THE FM WAS NOT EMBEDDED TO THE CATHETER TUBING. SEALED UNITS: NO FM WAS OBSERVED ON ANY OF THE UNITS RECEIVED ON THE SEALED PACKAGES. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO, THE RETURNED UNIT PROVIDED FOR EVALUATION DISPLAYED A LOOSE BLACK/BROWN SPEC ON THE CATHETER TUBING. INVESTIGATION CONCLUSION: THE DEFECT OF FOREIGN MATTER, AS STATED IN THE INVESTIGATION WAS CONFIRMED. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? YES; THE CUSTOMER EXPERIENCE WAS CONFIRMED BASED ON THE EVALUATION THAT WAS PERFORMED ON THE RETURNED UNIT (UNSEALED). WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO. IT WAS UNABLE TO REPRODUCE THE CUSTOMERS EXPERIENCE IN THE LABORATORY ENVIRONMENT. WAS THE DEVICE USED FOR TREATMENT OR DIAGNOSIS? TREATMENT. ROOT CAUSE DESCRIPTION: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. COMMENT: ALTHOUGH THE DEFECT OF FOREIGN MATTER REPORTED IN THIS INCIDENT WAS CONFIRMED, THE SOURCE OF THE FOREIGN IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE A NURSE ATTEMPTED TO START AN IV USING A 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER, SHE NOTICED FOREIGN MATTER ON THE CATHETER. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630436 24 G X 0.56 IN. BD INSYTE-N¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7121747

    Patients

    Seq Age Sex Outcome Treatment
    1 Other