BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN.

    MDR report key: 9377385 · Received November 26, 2019

    Report

    Report Number
    9610847-2019-00700
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 4, 2019
    Report Date
    January 30, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833130
    PMA / PMN Number
    K013800
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 9031835 AND THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO FURTHER INVESTIGATE THIS ISSUE, THREE PHYSICAL SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. BASED ON AN EVALUATION OF THE SAMPLES, OUR QUALITY TEAM WAS UNABLE TO CONFIRM THE REPORTED DEFECT OF NEEDLE RETRACTION FAILURE AS THE SAMPLES WERE RECEIVED WITH THE SAFETY DEVICE ACTIVATED. ONE SAMPLE DID DISPLAY A BROKEN NEEDLE AT THE NOTCH LOCATION. IT IS SUSPECTED THAT THIS DAMAGE WAS A RESULT OF EXCESSIVE FORCE DURING USE THAT RESULTED IN AN EXPOSED NEEDLE. OUR QUALITY TEAM ALSO IDENTIFIED THE DEFECT OF NEEDLE THROUGH CATHETER WITHIN THE RETURNED SAMPLES, THIS DEFECT MAY OCCUR IF THE SAFETY SHIELD IS ACTIVATED SLIGHTLY, THEN CAUSING A "SLING SHOT" LIKE MOTION OF THE NEEDLE THROUGH THE CATHETER WHEN MOVING BACK TO THE NEEDLE'S ORIGINAL POSITION. ALTHOUGH A DEFINITE CAUSE COULD NOT BE DETERMINED FOR THIS INCIDENT, IT IS POSSIBLE THAT THIS WAS A RESULT OF INCORRECT USAGE. IT IS IMPORTANT TO REFER TO THE INSTRUCTIONS FOR USE (IFU) WHEN USING THE SAF-T-INTIMA PRODUCT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY; HOWEVER, OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION PROCESS FOR DEFECTS THAT COULD CONTRIBUTE TO THIS INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PENETRATION OCCURRED DURING USE WITH A BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN.. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE HAS BEEN 5 INCIDENTS OVER THE LAST WEEK WHERE PATIENTS WHO HAVE BEEN HAVING INFUSIONS THROUGH THESE CANNULAS HAVE COMPLAINED OF INCREASE PAIN AND TENDERNESS TO THE AREA WHERE THE INSERTION HAS HAPPENED. ON CLOSER INSPECTION AND REMOVAL OF THESE CANNULAS THE STAFF HAVE NOTICED THE METAL NEEDLE TO STILL BE ATTACHED AND HAS NOT RETRACTED POST INSERTION. I HAVE 2 CANNULAS IN MY PROCESSION ONE WHICH YOU CAN SEE THE PLASTIC CANNULA IS BROKEN AND THE NEEDLE IS EXPOSED. THE NURSING STAFF BELIEVE IT IS FROM THE BATCH NUMBER LOT: 9031835 AND HAVE PULLED THESE FROM THE SHELF. THERE ARE APPROXIMATELY 30 OF THESE THAT WE HAVE REMOVED FROM STOCK AT THIS POINT IN TIME." 5 OCCURRENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    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 PENETRATION OCCURRED DURING USE WITH A BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN.. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THERE HAS BEEN 5 INCIDENTS OVER THE LAST WEEK WHERE PATIENTS WHO HAVE BEEN HAVING INFUSIONS THROUGH THESE CANNULAS HAVE COMPLAINED OF INCREASE PAIN AND TENDERNESS TO THE AREA WHERE THE INSERTION HAS HAPPENED. ON CLOSER INSPECTION AND REMOVAL OF THESE CANNULAS THE STAFF HAVE NOTICED THE METAL NEEDLE TO STILL BE ATTACHED AND HAS NOT RETRACTED POST INSERTION. I HAVE 2 CANNULAS IN MY PROCESSION ONE WHICH YOU CAN SEE THE PLASTIC CANNULA IS BROKEN AND THE NEEDLE IS EXPOSED. THE NURSING STAFF BELIEVE IT IS FROM THE BATCH NUMBER LOT: 9031835 AND HAVE PULLED THESE FROM THE SHELF. THERE ARE APPROXIMATELY 30 OF THESE THAT WE HAVE REMOVED FROM STOCK AT THIS POINT IN TIME." 5 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175033 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM 24 G X 0.75 IN. INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383313 9031835 30382903833130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other