BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CATHENA SAFETY IV CATHETER

    MDR report key: 16698882 · Received April 7, 2023

    Report

    Report Number
    8041187-2023-00148
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 7, 2023
    Report Date
    July 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    00382903868117
    PMA / PMN Number
    K172506
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 10-APR-2023. H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE 5 REPRESENTATIVE SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WERE NO ABNORMALITIES OR DAMAGES PRESENT. THE SAMPLES UNDERWENT OUR INTERNAL LEAKAGE TESTING, AND NO SIGNS OF LEAKAGE WERE OBSERVED. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANTI-REFLUX VALVE CAUSES AN OVERPRESSURE DURING THE INJECTIONS AT THE CT (INJECTION AT 4-5 CC/SEC) CAUSING: A LEAK ON THE 3-WAY VALVE; EXPLOSION OF THE TUBING; POOR SCANNER INJECTION MAKING DIAGNOSIS DIFFICULT; RISK OF BLOOD EXPOSURE ACCIDENT FOR THE MER WHO HAVE TO CLEAN UP AFTERWARDS THIS PROBLEM OCCURS WITH MOST OF THE CATHETERS USED, IT DOES NOT SEEM TO AFFECT ONLY ONE BATCH. CONSEQUENCES : LEAK ON THE 3-WAY VALVE; EXPLOSION OF THE TUBING; POOR SCANNER INJECTION MAKING DIAGNOSIS DIFFICULT; RISK OF BLOOD EXPOSURE ACCIDENT FOR THE MER WHO HAVE TO CLEAN UP AFTERWARDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANTI-REFLUX VALVE CAUSES AN OVERPRESSURE DURING THE INJECTIONS AT THE CT (INJECTION AT 4-5 CC/SEC) CAUSING: A LEAK ON THE 3-WAY VALVE, EXPLOSION OF THE TUBING, POOR SCANNER INJECTION MAKING DIAGNOSIS DIFFICULT, RISK OF BLOOD EXPOSURE ACCIDENT FOR THE MER WHO HAVE TO CLEAN UP AFTERWARDS THIS PROBLEM OCCURS WITH MOST OF THE CATHETERS USED, IT DOES NOT SEEM TO AFFECT ONLY ONE BATCH. CONSEQUENCES : LEAK ON THE 3-WAY VALVE, EXPLOSION OF THE TUBING, POOR SCANNER INJECTION MAKING DIAGNOSIS DIFFICULT, RISK OF BLOOD EXPOSURE ACCIDENT FOR THE MER WHO HAVE TO CLEAN UP AFTERWARDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD CATHENA SAFETY IV CATHETER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE ANTI-REFLUX VALVE CAUSES AN OVERPRESSURE DURING THE INJECTIONS AT THE CT (INJECTION AT 4-5 CC/SEC) CAUSING A LEAK ON THE 3-WAY VALVE, EXPLOSION OF THE TUBING, POOR SCANNER INJECTION MAKING DIAGNOSIS DIFFICULT, AND RISK OF BLOOD EXPOSURE ACCIDENT FOR THE MER WHO HAVE TO CLEAN UP AFTERWARDS THIS PROBLEM OCCURS WITH MOST OF THE CATHETERS USED. IT DOES NOT SEEM TO AFFECT ONLY ONE BATCH. CONSEQUENCES : LEAK ON THE 3-WAY VALVE, EXPLOSION OF THE TUBING, POOR SCANNER INJECTION MAKING DIAGNOSIS DIFFICULT AND RISK OF BLOOD EXPOSURE ACCIDENT FOR THE MER WHO HAVE TO CLEAN UP AFTERWARDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795739 BD CATHENA SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 386811 2238458 00382903868117

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown