BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM 24G X 0.75 IN WITH Y ADAPTER

    MDR report key: 6938174 · Received October 10, 2017

    Report

    Report Number
    9610847-2017-00104
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    August 24, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE#: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SINCE NO SAMPLE DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR FOR LOT NUMBER 7003629 WAS REVIEWED AND NO QNS OR OTHER EVENTS WERE RELATED TO THE COMPLAINT STATED BY THE CUSTOMER. MATERIAL 383313 WITH LOT NUMBER 7003629 WAS MANUFACTURED ON JANUARY 9, 2017. ACCORDING TO SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED. DURING THIS BATCH 475 SAMPLES WERE TAKEN BY QA TECH, FOR PERFORMED LEAK TEST BETWEEN CONNECTIONS THE PRODUCT IN FINAL ASSEMBLY, NO LEAKS WERE FOUND. ADDITIONALLY ALL FUNCTIONAL TEST MEETS SPECIFICATION CRITERIA REQUESTED DURING MANUFACTURING. INVESTIGATION CONCLUSION: WITHOUT DEFECTIVE SAMPLE OR PHOTO IT IS VERY DIFFICULT TO DETERMINATE THE ROOT OF CAUSE; HOWEVER; WITH THE PROVIDED INFORMATION FROM THE CUSTOMER THIS DEFECT COULD BE RELATED TO AN INCORRECT ACTIVATION OF THE DEVICE. IF THE DEVICE IS NOT ACTIVATED CORRECTLY IT CAN CAUSE A "SLING SHOT" AFFECT, SENDING THE NEEDLE TO HIS ORIGINAL POSITION, WHICH CAN RESULT IN CATHETER DAMAGE, CAUSING LEAKAGE. WE WERE NOT ABLE TO ASSOCIATE THE REPORTED DEFECT TO THE MFG. PROCESS WE WERE UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE ISSUE SINCE NO SAMPLE OR PHOTO WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM 24G X 0.75 IN. LEAKED AFTER A SUCCESSFUL VENIPUNCTURE. WHEN TESTED, IT WAS OBSERVED THAT THE CATHETER WAS PERFORATED. THE CATHETER THEN NEEDED TO BE REMOVED. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713881 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM 24G X 0.75 IN WITH Y ADAPTER INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 7003629

    Patients

    Seq Age Sex Outcome Treatment
    1 Other