BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRODUCER INTROSYTE 3F 3.2CM

    MDR report key: 12444684 · Received September 9, 2021

    Report

    Report Number
    1710034-2021-00793
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 11, 2021
    Report Date
    December 7, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    50382903840309
    PMA / PMN Number
    K974764
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/3/2021. H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TEN UNUSED INTROSYTE INTRODUCERS WITHIN SEALED PACKAGES. THE BLISTER PACKS WERE SEALED INSIDE A MISCELLANEOUS PLASTIC PACKAGING WITH MISCELLANEOUS STICKERS ADHERED TO THE PLASTIC PACKAGING. ALL COMPONENTS WERE PRESENT AND INTACT. VISUAL OBSERVATION OF THE DEVICES REVEALED THAT THE UNITS HAD NO ABNORMALITIES OR DAMAGE. AFTER VISUAL OBSERVATION, THE NEEDLE PORTION OF EACH UNIT WAS PULLED BACK THROUGH THE SPLITABLE SHEATH, WHILE OBSERVING FOR TRACTION AND WRINKLING. NO ABNORMALITIES WERE OBSERVED AND EACH UNIT DEMONSTRATED THE NEEDLE COULD BE REMOVED WITH NO RESISTANCE OR DAMAGE TO THE TUBING. BD WAS UNABLE TO CONFIRM ANY DEFECTS RELATED TO THE RETURNED SAMPLES. NO FURTHER TESTING COULD BE CONDUCTED, AS BASED ON THE EVENT DESCRIPTION ISSUES WERE EXPERIENCED WHILE WITHDRAWING THE GUIDEWIRE WHICH REMAINED ATTACHED, WRINKLING THE EXTENSION AND TRACTION. THIS COULD INDICATE THAT THE EXPERIENCED ISSUES COULD BE RELATED TO THE PICC AND NOT THE INTRODUCER AS THE INTRODUCER DOES NOT CONTAIN A GUIDEWIRE AND THE SHEATH IS A SPLITABLE SHEATH (CATHETER) THAT IS CRACKED AND THEN SPLIT FOR REMOVAL AFTER THE PICC IS FED THROUGH IT DURING PLACEMENT. 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 INTRODUCER INTROSYTE 3F 3.2CM WAS DAMAGED BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PERIPHERAL INSERTION CATHETER WAS PASSED AND THE GUIDE WIRE WAS ATTACHED, SHOWING A WRINKLING OF THE EXTENSION IN THE ATTEMPT TO REMOVE IT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. INITIAL REPORTER ADDRESS: (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRODUCER INTROSYTE 3F 3.2CM WAS DAMAGED BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PERIPHERAL INSERTION CATHETER WAS PASSED AND THE GUIDE WIRE WAS ATTACHED, SHOWING A WRINKLING OF THE EXTENSION IN THE ATTEMPT TO REMOVE IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341831 INTRODUCER INTROSYTE 3F 3.2CM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 384030 8297873 50382903840309

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown