MAUDE Adverse Event Report: NEPHRON PHARMACEUTICALS CORP. SODIUM CHLORIDE INHALATION SOLUTION, USP 0.9%

Lot Number N3738A

Device Problem Chemical Problem (2893)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 02/25/2015

Event Type  malfunction  

Event Description

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.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: SODIUM CHLORIDE INHALATION SOLUTION, USP 0.9%
• Type of Device: SODIUM CHLORIDE INHALATION SOLUTION
• Manufacturer (Section D): NEPHRON PHARMACEUTICALS CORP.; 4121 s.w 34th st. .; orlando FL 32811
• Manufacturer Contact: 4121 s.w. 34th st.; orlando, FL 32811 ; 8004434313
• MDR Report Key: 4651201
• MDR Text Key: 5595879
• Report Number: 1054871-2015-00002
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2015
• Device Lot Number: N3738A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1