BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SODIUM CHLORIDE INHALATION SOLUTION, USP 0.9%

    MDR report key: 4651201 · Received March 26, 2015

    Report

    Report Number
    1054871-2015-00002
    Event Type
    Malfunction
    Date Received
    March 26, 2015
    Date of Event
    February 25, 2015
    Report Date
    March 26, 2015
    Manufacturer
    NEPHRON PHARMACEUTICALS CORP.
    Product Code
    CAF
    PMA / PMN Number
    K113033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A NONCONFORMANCE INVESTIGATION (NCR 15-035) WAS COMPLETED; FURTHERMORE, THE INVESTIGATION DETERMINED THAT THE MOST PROBABLE ROOT CAUSES WERE IDENTIFIED AS HUMAN ERROR DURING A CLEANING PROCEDURE AND A LOW WATER FOR INJECTION FLOW RATE DURING THE CLEANING PROCEDURE. THE INVESTIGATION DETERMINED THAT THERE IS NO ANTICIPATED IMPACT TO THE NEPHRON PRODUCT; MOREOVER, THE PRODUCT FROM LOT N3738A EXPIRED IN JULY 2015. ALTHOUGH OUTSIDE OF SPECIFICATIONS, THE PH OF THE INVESTIGATED PRODUCT IS COMPARABLE TO THE PH OF OTHER INHALATION SOLUTION SUCH AS ALBUTEROL SULFATE INHALATION SOLUTION, 0.083% (PH = 3.0 - 5.0) AND IPRATROPIUM BROMIDE INHALATION SOLUTION, 0.02% (PH 3.0 - 4.0). DURING THE INTERNAL NONCONFORMANCE INVESTIGATION, THE FOLLOWING POTENTIAL CAUSES OF LOW PH WERE EVALUATED: HUMAN ERROR DURING THE PERFORMANCE OF THE CIP BETWEEN THE FORMULATION OF A RACEPINEPHRINE BATCH# R3021 AND A SODIUM CHLORIDE BATCH# N3738; HUMAN ERROR DURING THE FORMULATION OF BATCH# N3738; INSTRUMENT ERROR DURING PH TESTING; HUMAN ERROR DURING PH TESTING; AND A LOW WATER FOR INFECTION (WFI) FLOW RATE. THE INVESTIGATION CONCLUDED THAT THE MOST PROBABLE ROOT CAUSES WERE HUMAN ERROR DURING THE PERFORMANCE OF THE CIP AND LOW WFI FLOW DURING THE CIP. THE NONCONFORMANCE INVESTIGATION WAS FINALIZED, AND THE 24-MONTH STABILITY SAMPLE ANALYSIS CONFIRMED THE NONCONFORMANCE. IT SHOULD BE NOTED THAT LOT N3738A IS NOW EXPIRED. IT SHOULD ALSO BE NOTED THAT OTHER NEPHRON INHALED PRODUCTS MEET SPECIFICATIONS WITH A SIMILAR SAME PH AS THE INVESTIGATED PRODUCT. SEE SCANNED PAGES.

    Additional Manufacturer Narrative · 1

    AS STATED PREVIOUSLY, NEPHRON BECAME AWARE INTERNALLY OF A PRODUCT MALFUNCTION OF LOW PH THAT WAS REPORTED AS ASSOCIATED WITH SODIUM CHLORIDE INHALATION SOLUTION, 0.95. THE NONCONFORMANCE WAS OBSERVED IN STABILITY SAMPLES FROM LOT N3738A AT THE 18-MONTH TIME POINT. THE LOW PH IN THE STABILITY SAMPLE WAS CONFIRMED DURING THE ANALYSIS OF RETAINED PRODUCT SAMPLES. THE PRODUCT EXPIRES IN JULY 2015. AT THIS TIME, NEPHRON HAS NOT RECEIVED ANY REPORTS OF DEVICE-RELATED ADVERSE EVENTS ASSOCIATED WITH LOT N3738A. AN INVESTIGATION IS IN PROCESS REGARDING THE ROOT CAUSE OF THE NONCONFORMANCE.

    Description of Event or Problem · 1

    NEPHRON PHARMACEUTICALS CORP BECAME AWARE OF A MEDICAL DEVICE ACCESSORY WITH LOW PH ON (B)(6) 2015, THAT WAS REPORTED INTERNALLY AS ASSOCIATED WITH SODIUM CHLORIDE INHALATION SOLUTION, USP 0.9%. DURING THE 18-MONTH STABILITY SAMPLE ANALYSIS, IT WAS DETERMINED THAT THE PH OF THE SAMPLES DID NOT MEET THE PH SPECIFICATION. THE PH OF THE SUSPECTED SAMPLE WAS DETERMINED TO BE 4.3; HOWEVER, THE ACCEPTABLE USP SPECIFICATION RANGE IS 4.5 TO 7.0 FOR THE FINISHED PRODUCT. AN INVESTIGATION IS CURRENTLY PENDING INTO THE ROOT CAUSE OF THE NONCONFORMANCE; HOWEVER, NO PATIENT COMPLAINTS WERE ASSOCIATED WITH THE PRODUCT PROBLEM DESCRIBED IN THIS INITIAL REPORT.

    Description of Event or Problem · 1

    NEPHRON PHARMACEUTICALS CORPORATION BECAME AWARE OF A MEDICAL DEVICE ACCESSORY WITH LOW PH ON (B)(6) 2015, THAT WAS REPORTED INTERNALLY AS ASSOCIATED WITH SODIUM CHLORIDE INHALATION SOLUTION, USP 0.9%. DURING THE 18-MONTH STABILITY SAMPLE ANALYSIS, IT WAS DETERMINED THAT THE PH OF THE SAMPLES DID NOT MEET THE PH SPECIFICATION. THE PH OF THE SUSPECTED SAMPLE WAS DETERMINED TO BE 4.3; HOWEVER, THE ACCEPTABLE USP SPECIFICATION RANGE IS 4.5 TO 7.0 FOR THE FINISHED PRODUCT. THE LOW PH WAS ALSO CONFIRMED IN RETAINED SAMPLES (PH = 4.3). THE PH ALSO DID NOT MEET SPECIFICATIONS DURING THE 24-MONTH STABILITY SAMPLE ANALYSIS. NO PATIENT COMPLAINTS WERE ASSOCIATED WITH THE PRODUCT PROBLEM DESCRIBED IN THIS INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201761 SODIUM CHLORIDE INHALATION SOLUTION, USP 0.9% SODIUM CHLORIDE INHALATION SOLUTION CAF NEPHRON PHARMACEUTICALS CORP. NA N3738A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA