BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER

    MDR report key: 10065354 · Received May 18, 2020

    Report

    Report Number
    8041187-2020-00266
    Event Type
    Malfunction
    Date Received
    May 18, 2020
    Date of Event
    April 27, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS FROM LOTS 9167787, 9171531, AND 9317723 LEAKED FROM BETWEEN THE LUER-LOCK PLUG AND FLASHBACK CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAINT REVOLVES AROUND A LEAK BETWEEN THE LUER-LOCK PLUG AND THE FLASH-BACK CHAMBER".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9167787. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2019-06-16. MEDICAL DEVICE LOT #: 9171531. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2019-06-20. MEDICAL DEVICE LOT #: 9317723. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2019-11-13. 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 AN UNSPECIFIED NUMBER OF BD VENFLON¿ PRO SAFETY PERIPHERAL SAFETY IV CATHETERS FROM LOTS 9167787, 9171531, AND 9317723 LEAKED FROM BETWEEN THE LUER-LOCK PLUG AND FLASHBACK CHAMBER. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAINT REVOLVES AROUND A LEAK BETWEEN THE LUER-LOCK PLUG AND THE FLASH-BACK CHAMBER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531986 BD VENFLON PRO SAFETY PERIPHERAL SAFETY IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other