BEUDAMED
    FDA Adverse Event Summary report: N

    SODIUM CHLORIDE INHALATION SOLUTION 3%

    MDR report key: 12934089 · Received December 3, 2021

    Report

    Report Number
    MW5105803
    Date Received
    December 3, 2021
    Report Date
    September 20, 2021
    Manufacturer
    NEPHRON SC, INC.
    Product Code
    CAF
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    POTENTIAL FOR ERROR INVOLVING SODIUM CHLORIDE 3% INHALATION SOLUTION (NDC: 0487-9003-60) AND SODIUM CHLORIDE 7% INHALATION SOLUTION. (NDC: 0487- 9007-60) MANUFACTURED BY NEPHRON PHARMACEUTICALS. PRODUCTS ARRIVE IN GO-COUNT BOXES DIFFERENTIATED ONLY BY NDC, PERCENTAGE STRENGTH, AND COLORED PIXELATED STRIPE ON BOX (BROWN FOR 3% AND GRAY FOR 7%). UNIT DOSE VIAL ITSELF IS CLEAR PLASTIC WITH PRODUCT DESCRIPTION EMBOSSED INTO PLASTIC WITH ONLY DIFFERENTIATING FACTORS BEING PERCENTAGE STRENGTH. WORDING IS VERY DIFFICULT TO READ. UNIT DOSE PRODUCTS ARE THE SAME IN SIZE, APPEARANCE, AND VOLUME. NO OVERWRAP OR BARCODE IS AVAILABLE FOR SCANNING. TYPICALLY, INSTITUTION RECEIVES SODIUM CHLORIDE 3% INHALATION SOLUTION FROM A HOSPITAL SYSTEM CENTRAL PACKAGING FACILITY IN WHICH VIALS ARE INDIVIDUALLY WRAPPED AND BARCODED. HOWEVER, AT TIME WHEN THESE BECAME UNAVAILABLE THROUGH CENTRAL PACKAGER, BULK BOX WAS OBTAINED CREATING POTENTIAL FOR ERROR IN DISPENSING. (B)(6). SUBMISSION ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827742 SODIUM CHLORIDE INHALATION SOLUTION 3% NEBULIZER (DIRECT PATIENT INTERFACE) CAF NEPHRON SC, INC.
    1827743 SODIUM CHLORIDE INHALATION SOLUTION 7% NEBULIZER (DIRECT PATIENT INTERFACE) CAF NEPHRON SC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown