BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MINILOC PORT ACCESS NEEDLE

    MDR report key: 18293627 · Received December 8, 2023

    Report

    Report Number
    3006260740-2023-05602
    Event Type
    Malfunction
    Date Received
    December 8, 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. UPON INITIAL REVIEW OF ALL PROVIDED INFORMATION, IT APPEARED THAT A REPORTABLE EVENT OCCURRED ON A MINILOC PORT ACCESS NEEDLE AND A SAFESTEP PORT ACCESS NEEDLE AND WERE REPORTED UNDER MEDWATCH REPORT 3006260740-2023-05602 AND 3006260740-2023-05601. AFTER FURTHER REVIEW, IT WAS DETERMINED THAT NO DEVICE MALFUNCTION HAS BEEN REPORTED ON THE MINILOC PORT ACCESS NEEDLE. 3006260740-2023-05602 WILL BE VOIDED. THE INFORMATION PROVIDED DOES NOT REASONABLY SUGGEST THE EVENT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OF A PATIENT, USER, OR OTHER PERSON. THEREFORE, THIS EVENT IS DEEMED NOT REPORTABLE PER 21 CFR PART 803.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MS&S "NURSE REQUESTING THE PLASTIC MATERIALS USED FOR THE SAFESTEP AND MINILOC NEEDLES. 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 SAFESTEP NEEDLES ARE DEHP FREE." MS&S RESPONSE: "INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHERIMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND LDPE (LOW-DENSITY POLYETHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURING ACRYLIC ADHESIVE, AND SILICONE. THE NEEDLE FOR THE SAFESTEP IS 304 STAINLESS STEEL, WITCH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE SAFESTEP NEEDLE 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-CURE ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH THE MINILOC AND SAFESTEP NEEDLES AND PACKAGING ARE DEHP FREE." THIS REPORT ADDRESSES THE MINILOC NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA MS&S "NURSE REQUESTING THE PLASTIC MATERIALS USED FOR THE SAFESTEP AND MINILOC NEEDLES. 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 SAFESTEP NEEDLES ARE DEHP FREE." MS&S RESPONSE: "INFORMED THE NEEDLE FOR THE MINILOC NEEDLE IS 304 STAINLESS STEEL, WITH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE MINILOC NEEDLE IS PVC (POLYVINYL CHLORIDE). OTHER MATERIALS INCLUDE POLYPROPYLENE, POLYETHERIMIDE, ABS (ACRYLONITRILE BUTADIENE STYRENE), RIGID PVC, AND LDPE (LOW-DENSITY POLYETHYLENE). THE FLUID PATH MATERIALS ARE FLEXIBLE PVC, RIGID PVC, ABS, 304 STAINLESS STEEL, UV-CURING ACRYLIC ADHESIVE, AND SILICONE. THE NEEDLE FOR THE SAFESTEP IS 304 STAINLESS STEEL, WITCH ACRYLIC ADHESIVE AND SILICONE OIL. THE TUBING FOR THE SAFESTEP NEEDLE 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-CURE ACRYLIC ADHESIVE, AND 304 STAINLESS STEEL. BOTH THE MINILOC AND SAFESTEP NEEDLES AND PACKAGING ARE DEHP FREE." THIS REPORT ADDRESSES THE MINILOC NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65115 BARD MINILOC PORT ACCESS NEEDLE SET, ADMINISTRATION, INTRAVASCULAR FPA C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other