BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 10305944 · Received July 21, 2020

    Report

    Report Number
    1710034-2020-00468
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    June 22, 2020
    Report Date
    August 14, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K110443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH TWO PHOTOS OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 8162948, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS BUT COULD NOT IDENTIFY ANY PHYSICAL/MECHANICAL DAMAGE TO THE UNIT. THERE WAS NOT ENOUGH VISIBLE EVIDENCE IN THE PROVIDED PHOTOS TO VERIFY THE REPORTED ISSUE. SINCE NO DEFECT COULD BE OBSERVED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SILICONE PART OF THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS NOTICED TO BE "PERFORATED AND ROUGH". THIS WAS NOTICED PRIOR TO USE WITH 2 DIFFERENT CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WHEN REMOVED FROM THE PACKAGING FOR PUNCTURE, THE PART OF THE SILICONE THAT IS INSIDE THE PATIENT'S VEIN IS PERFORATED AND ROUGH. CUSTOMER INFORMED: BOTH TIPS WERE PERFORATED. THE NEEDLE WAS NOT THROUGH CATHETER. IT WAS NOTICED PRIOR PUNCTURE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SILICONE PART OF THE BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER WAS NOTICED TO BE "PERFORATED AND ROUGH". THIS WAS NOTICED PRIOR TO USE WITH 2 DIFFERENT CATHETERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "WHEN REMOVED FROM THE PACKAGING FOR PUNCTURE, THE PART OF THE SILICONE THAT IS INSIDE THE PATIENT'S VEIN IS PERFORATED AND ROUGH. CUSTOMER INFORMED: BOTH TIPS WERE PERFORATED. THE NEEDLE WAS NOT THROUGH CATHETER. IT WAS NOTICED PRIOR PUNCTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770217 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8162948

    Patients

    Seq Age Sex Outcome Treatment
    1 Other