BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OBTURATOR FOR VENFLON/SAFELON1.0X32

    MDR report key: 9444278 · Received December 10, 2019

    Report

    Report Number
    1710034-2019-01311
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 25, 2019
    Report Date
    February 6, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED (B)(4) OBTURATORS WITHIN PACKAGES FROM REFERENCE NUMBER 394252, LOT NUMBER 7173734. FOUR OF THE UNITS WERE OPENED. EACH PACKAGE DISPLAYED A BROWNISH SUBSTANCE INSIDE THE PACKAGES AND SOME ON THE UNITS. IN ADDITION, THREE PHOTOGRAPHS WERE ALSO SUBMITTED WHICH DISPLAYED SIMILARITIES TO THAT OF THE RETURNED UNITS. THROUGH THE INVESTIGATION OF THE UNITS, THE BROWNISH SUBSTANCE WAS CONFIRMED TO EASILY WIPE AWAY WITH A SWAP STICK. FURTHER FTIR ANALYSIS CONCLUDED THAT THE MATERIAL IN THE BLISTER PACKS HAS COMPONENTS SIMILAR TO THAT OF ACETIC ACID, SODIUM SALT WHICH DOES NOT MATCH THE MATERIAL OF THE OBTURATORS. ALTHOUGH THE FAILURES STATED IN THE REPORTED ISSUE WERE CONFIRMED WITH THE UNIT PROVIDED FOR INVESTIGATION, BD COULD NOT ESTABLISH A DEFINITE ROOT CAUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE OBTURATOR FOR VENFLON/SAFELON1.0X32 THE PACKAGING WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN OUR STOCK, BROWN DISCOLORATION WAS FOUND ON AND IN THE PRIMARY PACKAGING OF ARTICLE BD VENFLON (REF 394252) WITH CHARGE 7173734 (EXP. JUNE 2020) DURING PICKING.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BEFORE USE OF THE OBTURATOR FOR VENFLON/SAFELON1.0X32 THE PACKAGING WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN OUR STOCK, BROWN DISCOLORATION WAS FOUND ON AND IN THE PRIMARY PACKAGING OF ARTICLE BD VENFLON (REF 394252) WITH CHARGE 7173734 (EXP. JUNE 2020) DURING PICKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243480 OBTURATOR FOR VENFLON/SAFELON1.0X32 INTRAVENOUS CANNULAS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7173734

    Patients

    Seq Age Sex Outcome Treatment
    1 Other