BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTURATOR FOR VENFLON/SAFELON1.0X32

    MDR report key: 10571045 · Received September 22, 2020

    Report

    Report Number
    1710034-2020-00606
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    August 31, 2020
    Report Date
    November 17, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS WHICH DISPLAYED THE BD OBTURATOR DISPENSER BOX WITH NO LABEL PRESENT TO IDENTIFY THE GAGE, MATERIAL, OR LOT OF THE PRODUCT INSIDE THE SHIPPER. THE REPORTED ISSUE WAS CONFIRMED. SHIPPER LABELS ARE PRINTED OFF AND PLACED ON THE DISPENSER BOXES BY OPERATORS DURING THE PACKAGING PROCESS. IN THIS CASE AN OPERATOR MOST LIKELY DID NOT PLACE A DISPENSER LABEL ONTO THE BOX BEFORE PLACING IT INTO A SHIPPER. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OBTURATOR FOR VENFLON/SAFELON1.0X32 WAS DELIVERED WITHOUT A LABEL. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "ONE PACKAGING UNIT OF THE REF 394252 WAS DELIVERED WITHOUT LABELS, LOT NUMBER 9200654."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE OBTURATOR FOR VENFLON/SAFELON1.0X32 WAS DELIVERED WITHOUT A LABEL. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "ONE PACKAGING UNIT OF THE REF 394252 WAS DELIVERED WITHOUT LABELS, LOT NUMBER 9200654."

    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 OBTURATOR FOR VENFLON/SAFELON1.0X32 WAS DELIVERED WITHOUT A LABEL. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "ONE PACKAGING UNIT OF THE REF 394252 WAS DELIVERED WITHOUT LABELS, LOT NUMBER 9200654."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035513 OBTURATOR FOR VENFLON/SAFELON1.0X32 INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9200654

    Patients

    Seq Age Sex Outcome Treatment
    1 Other