BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD SAFESTEP INFUSION SET

    MDR report key: 18314874 · Received December 12, 2023

    Report

    Report Number
    3006260740-2023-05670
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 17, 2023
    Report Date
    December 27, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    PMA / PMN Number
    UNK
    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. INITIAL MEDWATCH REPORT WAS SUBMITTED, UPON FURTHER REVIEW IT WAS FOUND THAT THIS MEDWATCH REPORT 3006260740-2023-05670 IS A DUPLICATE FILE AND HAS BEEN VOIDED. THE ORIGINAL EVENT WAS SUBMITTED ON MEDWATCH REPORT 3006260740-2023-05602.

    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 DATE OF EVENT WAS NOT PROVIDED BY THE COMPLAINANT/REPORTER, THE DATE REFLECTED IN THIS REPORT IS THE DATE BD BECAME AWARE OF THE EVENT. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT NURSED STATES THEY HAVE NOTICED THAT THE PLASTIC TUBING IN THE SAFESTEP NEEDLE BREAKS DOWN WHEN INFUSING BLINATUMOMAB COMPARED TO THE MINILOC NEEDLE. SHE IS WONDERING IF THEY BOTH HAVE DIFFERENT PLASTIC MATERIALS ALSO INQUIRING IF THE MINILOC AND STEP NEEDLE ARE DEHP FREE. RESPONSE: INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHEREMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE, RIGID PVC, AND LDPE (LOW-DENSITY POLYTHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURED ACRYLIC ADHESIVE, AND SILICONE. THE TUBING FOR THE SAFESTEP IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND POLYCARBONATE. THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, POLYCARBONATE, SILICONE, UV-CURED ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH MINILOC AND SAFESTEP NEEDLES AND PACKAGING ARE DEHP FREE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT NURSED STATES THEY HAVE NOTICED THAT THE PLASTIC TUBING IN THE SAFESTEP NEEDLE BREAKS DOWN WHEN INFUSING BLINATUMOMAB COMPARED TO THE MINILOC NEEDLE. SHE IS WONDERING IF THEY BOTH HAVE DIFFERENT PLASTIC MATERIALS ALSO INQUIRING IF THE MINILOC AND STEP NEEDLE ARE DEHP FREE. RESPONSE: INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHEREMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE, RIGID PVC, AND LDPE (LOW-DENSITY POLYTHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURED ACRYLIC ADHESIVE, AND SILICONE. THE TUBING FOR THE SAFESTEP IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND POLYCARBONATE. THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, POLYCARBONATE, SILICONE, UV-CURED ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH MINILOC AND SAFESTEP NEEDLES AND PACKAGING ARE DEHP FREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693923 BARD SAFESTEP INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other