BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SODIUM CHLORIDE INHALATION SOLUTION, USP 100%

    MDR report key: 4834592 · Received June 8, 2015

    Report

    Report Number
    1054871-2015-00003
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 8, 2015
    Manufacturer
    NEPHRON PHARMACEUTICALS CORP.
    Product Code
    CAF
    PMA / PMN Number
    K120051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A SUBSEQUENT INTERNAL INVESTIGATION, IT WAS DETERMINED THAT TWO OF THE RETAIN SAMPLES DID NOT MEET SPECIFICATIONS AT ROOM TEMPERATURE. THERE WERE NO COMPLAINTS OR ADVERSE EVENTS ASSOCIATED WITH THE MALFUNCTION THAT WERE REPORTED TO THE MANUFACTURER OF THIS REPORT. A RETAIN SAMPLE ANALYSIS OF 21 LOTS DID NOT YIELD THE SAME RESULTS IN 19 OF THE LOTS. TWO LOTS, LOT N4745A (SODIUM CHLORIDE INHALATION SOLUTION, 3%) AND LOT N4753A (SODIUM CHLORIDE INHALATION SOLUTION, 7%), DID DEMONSTRATE THE SAME DYE INGRESS OUT-OF-SPECIFICATION AS LOT N3BLLA (SODIUM CHLORIDE INHALATION SOLUTION, 10%). AT THIS TIME, NEPHRON HAS NOT RECEIVED ANY REPORTS OF DEVICE-RELATED ADVERSE EVENTS OR COMPLAINTS ASSOCIATED WITH LOT N3511A, LOT N4745A, OR LOT N4753A. NEPHRON IS CURRENTLY CONDUCTING AN INVESTIGATION REGARDING THE ROOT CAUSE OF THE MALFUNCTION. THE DEVICE MANUFACTURE DATE FOR LOT N4745A IS OCTOBER 2014. THE DEVICE MANUFACTURE DATE FOR LOT N4753A IS DECEMBER 2014.

    Additional Manufacturer Narrative · 1

    AS STATED PREVIOUSLY, NEPHRON BECAME AWARE INTERNALLY OF A PRODUCT MALFUNCTION THAT WAS REPORTED AS ASSOCIATED WITH SODIUM CHLORIDE INHALATION SOLUTION, 10.0%. THE DYE INGRESS OUT-OF=SPEC WAS OBSERVED IN STABILITY SAMPLES FROM LOT N3511A AT EXPIRY. AT THIS TIME, NEPHRON HAS NOT RECEIVED ANY REPORTS OF DEVICE-RELATED ADVERSE EVENTS OR COMPLAINTS ASSOCIATED WITH LOT N3511A. NEPHRON IS CURRENTLY CONDUCTING AN INVESTIGATION REGARDING THE ROOT CAUSE OF THE MALFUNCTION. A RETAIN SAMPLE ANALYSIS IS ALSO CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    NEPHRON PHARMACEUTICALS CORP BECAME AWARE OF A MEDICAL DEVICE ACCESSORY THAT FAILED TO MEET SPECS ON (B)(6) 2015, THAT WAS REPORTED INTERNALLY. THE MEDICAL DEVICE ACCESSORY WAS DETERMINED TO BE SODIUM CHLORIDE INHALATION SOLUTION, ESP 10.0%. DURING THE VISUAL DYE INGRESS TEST AT EXPIRY, THE PRODUCT FROM STABILITY LOT N3511A DID NOT MEET SPECS AT ROOM TEMPERATURE. THERE WERE NO COMPLAINTS OR ADVERSE EVENTS ASSOCIATED WITH THE MALFUNCTION THAT WERE REPORTED TO THE MFR AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369446 SODIUM CHLORIDE INHALATION SOLUTION, USP 100% SODIUM CHLORIDE INHALATION SOLUTION CAF NEPHRON PHARMACEUTICALS CORP. NA N3511A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA