BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINILOC SAFETY INFUSION SET 19G X 0.75IN

    MDR report key: 20815474 · Received December 1, 2024

    Report

    Report Number
    3006260740-2024-07132
    Event Type
    Malfunction
    Date Received
    December 1, 2024
    Date of Event
    July 12, 2024
    Report Date
    February 13, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    UDI-DI
    00801741047527
    PMA / PMN Number
    K050600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE COMPLAINT OF A CRACK OR BREAKAGE IN THE INFUSION SET IS CONFIRMED; HOWEVER, THE EXACT CAUSE IS UNKNOWN. ONE PHOTOGRAPH OF A 19G MINILOC INFUSION SET WAS RETURNED FOR EVALUATION. AN INITIAL VISUAL OBSERVATION OF THE PHOTOGRAPH SHOWED A BREAK AND SEPARATION OF THE HUB FROM THE TUBING OF THE SAMPLE. THE SAMPLE IN THE PHOTO WAS IN USE AND USE RESIDUE WAS OBSERVED INSIDE THE TUBING. THE TUBING WAS OBSERVED TO BE CLAMPED PROXIMAL TO WHERE THE HUB WOULD BE. NO DETAILS OF BREAK SITE COULD BE DISCERNED FROM THE RETURNED PHOTOGRAPH. THERE WERE NO DISTINGUISHING FEATURES IN THE RETURNED PHOTOGRAPH OF THE DEVICE WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT OUT-PATIENT CLIENT ADMITTED ON (B)(6) 2024 AT 13:30, PATIENT AT HOME WITH PAC IN PLACE WITH HOME INFUSION OF BLINATUMOMAB INFUSING TO PAC. HMH HOMECARE INFUSION OF BLINATUMOMAB TUBING SEVERED AT THE FILTER SITE. NURSE MANAGER NOTIFIED LINE CHANGED AND PATIENT WAS DISCHARGED. NO HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT OUT-PATIENT CLIENT ADMITTED (B)(6) 2024 AT 13:30, PATIENT AT HOME WITH PAC IN PLACE WITH HOME INFUSION OF BLINATUMOMAB INFUSING TO PAC. HMH HOMECARE INFUSION OF BLINATUMOMAB TUBING SEVERED AT THE FILTER SITE. NURSE MANAGER NOTIFIED LINE CHANGED AND PATIENT WAS DISCHARGED. NO HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438273 MINILOC SAFETY INFUSION SET 19G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN 00801741047527

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male Other