BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 9918014 · Received April 2, 2020

    Report

    Report Number
    2243072-2020-00552
    Event Type
    Injury
    Date Received
    April 2, 2020
    Date of Event
    March 9, 2020
    Report Date
    April 28, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: A.2. AGE AT TIME OF EVENT: 71; A.2. DATE OF BIRTH:(B)(6) 1949; A.3. SEX: FEMALE; B.3. DATE OF EVENT: (B)(6)2020; B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT PATIENT EXPERIENCED REDNESS AT INSERTION SITE, BRUISING, AND CELLULITIS WITH AN BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS) WE HAD INCIDENT INVOLVING PATIENT WHO RECEIVED ADMINISTRATION OF RITUXIMAB VIA THE SYRINGE PUMP. PATIENT HAS DEVELOPED REDNESS AT THE SITE OF ADMINISTRATION, AND TWO OF THEM SIGNIFICANT EXPANSIVE BRUISING, ONE WITH POSSIBLE CELLULITIS AND REQUIRED ADMISSION. D.4 MEDICAL DEVICE CATALOG #: 383318. D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC S.A. DE C.V. ¿ NOGALES, MEXICO / 84048. G.2 MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC S.A. DE C.V. ¿ NOGALES, MEXICO / 84048.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED REDNESS AT INSERTION SITE, BRUISING, AND CELLULITIS WITH AN BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS) WE HAD INCIDENT INVOLVING PATIENT WHO RECEIVED ADMINISTRATION OF RITUXIMAB VIA THE SYRINGE PUMP. PATIENT HAS DEVELOPED REDNESS AT THE SITE OF ADMINISTRATION, AND TWO OF THEM SIGNIFICANT EXPANSIVE BRUISING, ONE WITH POSSIBLE CELLULITIS AND REQUIRED ADMISSION.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. THERE ARE CURRENT QUALITY CONTROLS IN PLACE TO DETECT THIS TYPE OF PRODUCT MALFUNCTION DURING THE PRODUCTION PROCESS. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED REDNESS AT INSERTION SITE, BRUISING, AND CELLULITIS WITH AN UNSPECIFIED BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (3 OF 3 COMPLAINTS) WE HAD INCIDENT INVOLVING PATIENT WHO RECEIVED ADMINISTRATION OF RITUXIMAB VIA THE SYRINGE PUMP. PATIENT HAS DEVELOPED REDNESS AT THE SITE OF ADMINISTRATION, AND TWO OF THEM SIGNIFICANT EXPANSIVE BRUISING, ONE WITH POSSIBLE CELLULITIS AND REQUIRED ADMISSION. RITUXIMAB HAS BEEN GIVEN VIA SUBQ USING SAF-T-INTIMA AND A SYRINGE (OVER SLOW ADMINISTRATION) INITIALLY (NO REPORTED INCIDENTS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380979 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other