BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN

    MDR report key: 9536053 · Received December 31, 2019

    Report

    Report Number
    8041187-2019-01053
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 13, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    UDI-DI
    30382903813231
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS AND THREE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. UPON VISUAL INSPECTION, A DAMAGED CATHETER TIP WAS OBSERVED ON TWO OF THEM AND NEEDLE PIERCED THROUGH CATHETER WAS OBSERVED ON THE THIRD; THEREFORE THE INCIDENT COULD BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE INVESTIGATION, THE CATHETER DAMAGE COULD HAVE BEEN CAUSED BY THE NEEDLE PIERCING THROUGH THE CATHETER. NEEDLE THROUGH CATHETER WOULD HAVE OCCURRED DURING PRODUCT APPLICATION WHEN THE PRODUCT WAS MANIPULATED OR DURING ASSEMBLY OF CATHETER. A PROJECT HAS BEEN STARTED, CAPA#590840, TO FURTHER ADDRESS ACTIONS REQUIRED TO PREVENT IT FROM OCCURRING DURING THE ASSEMBLY OF THE CATHETER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN EXPERIENCED CATHETER TIP DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED UNEVEN CATHETER TIP BETWEEN NEEDLE EN PU.

    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, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN EXPERIENCED CATHETER TIP DAMAGE/DEFORMATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED UNEVEN CATHETER TIP BETWEEN NEEDLE EN PU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331619 BD INSYTE-W¿ IV CATHETER WITH WINGS 22GA 1.00IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 381323 9142935 30382903813231

    Patients

    Seq Age Sex Outcome Treatment
    1 Other