BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER

    MDR report key: 7588955 · Received June 11, 2018

    Report

    Report Number
    8041187-2018-00191
    Event Type
    Malfunction
    Date Received
    June 11, 2018
    Date of Event
    May 15, 2018
    Report Date
    September 7, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FROM THE RETURNED SAMPLE, IT WAS OBSERVED THAT THE NEEDLE HAD PIERCE THROUGH THE CATHETER. THE MANUFACTURING PROCESS WAS REVIEWED. THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES THAT COULD HAVE CAUSED THIS NONCONFORMANCE. THE MANUFACTURING PROCESS INCLUDES AN AUTOMATED VISION INSPECTION MACHINE THAT WILL REJECT PARTS NOT MEETING LIE DISTANCE REQUIREMENT. NEEDLE PIERCE THROUGH CATHETER WILL AUTOMATICALLY BE REJECTED AS THE LIE DISTANCE WILL BE OUT OF SPECIFICATION. INVESTIGATION CONCLUSION: THERE IS AN AUTOMATED VISION INSPECTION SYSTEM THAT REJECTS PART NOT MEETING LIE DISTANCE REQUIREMENT. A NEEDLE PIERCE THOUGH CATHETER DEFECT WILL AUTOMATICALLY BE REJECTED AS THE LIE DISTANCE WILL BE OUT OF SPECIFICATION. THERE IS NO PROCESS IN THE MANUFACTURING FACILITIES THAT COULD HAVE CAUSED THIS NONCONFORMANCE. THEREFORE, THIS REPORTED NONCONFORMANCE COULD HAVE OCCURRED OUT OF THE MANUFACTURING FACILITIES.

    Additional Manufacturer Narrative · 0

    DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER, IT LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER, IT LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7233326, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2017-09-28. MEDICAL DEVICE LOT #: 7233318, MEDICAL DEVICE EXPIRATION DATE: 2020-08-31, DEVICE MANUFACTURE DATE: 2017-12-11. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER, IT LEAKED. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432137 BD VENFLON¿ PRO SAFETY SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other