MAUDE Adverse Event Report: EXCELSIOR MEDICAL LLC 10ML IN A 10ML SYRINGE, NACL 0.9%; 0.9% SODIUM CHLORIDE INJECTION, USP

Model Number 1011-240

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burning Sensation (2146)

Event Date 03/10/2016

Event Type  malfunction  

Manufacturer Narrative

The syringe related to this complaint has not been returned, therefore an evaluation could not be performed.Although the original sample was not returned, samples from the same lot were obtained from the user facility.These samples along with retention samples, obtained from the manufacturing facility for the lot in question, were tested to determine if the fluid is consistent with product labeling.The results of the testing showed that both sample sets contained 0.9% sodium chloride, within the specified range indicated on the product labeling.At this time however, no conclusion or root cause can be provided as the investigation into this event is still being performed.Additionally, device history records for this lot were reviewed and no similar instances were found.A follow-up report will be submitted once the investigation is complete.

Event Description

Customer reported that a patient felt a burning sensation in their arm when the saline was pushed in.The syringe was not returned for evaluation.

Manufacturer Narrative

The investigation into this incident has been completed and it was determined that the most likely root cause was alcohol contamination during administration of therapy.The customer retained the two saline syringes used on the patient and performed testing to determine if any contaminants were present within the 0.9% saline solution; the results showed trace amounts of ethanol and propanol.As the origin of the ethanol and propanol was unknown, testing of unopened syringes from the same lot (#3126312) was performed to determine if contamination existed within other syringes; no evidence of ethanol or propanol was found.In order to provide further evidence, excelsior medical duplicated the testing performed by the customer on unopened retention samples from lot#3126312.Test results also showed no evidence of ethanol or propanol.Investigation was performed to determine the potential source of the alcohol contamination, and it was determined that it could not have occurred at the manufacturing facility as excelsior medical uses a closed system within a cleanroom environment to fill and cap syringes.This system does not allow for the introduction of any outside contaminants as the syringe is filled and the fluid path sealed prior to exiting the system.Additionally, saline lots are received in sealed bags with certificates of compliance, certifying that they contain proper levels of 0.9% sodium chloride per ups requirements.In contrast, hospital and patient care typically involves the use of alcohol based products for the purposes of personal hygiene, prepping of surgical areas and intravenous medication.As a result, the chances of contaminating a syringe tip or patient injection site with alcohol in a hospital environment is high.Therefore it has been concluded, based on the tests performed and the review of potential areas of contamination that the introduction of alcohol most likely occurred at the customer facility during the administration of therapy.In order to determine the potential impact that this alcohol contamination could have on the patient, two separate clinical evaluations were performed (see attachments).These evaluations concluded that the level of alcohol found during testing was at a level which posed no risk to the patient and were found to be approximately 1000 times lower than what could be found in a common nutritional intravenous solution.Based on the results of this investigation and the clinical assessments performed, this matter has been closed with no further action being required.(b)(4).

• Brand Name: 10ML IN A 10ML SYRINGE, NACL 0.9%
• Type of Device: 0.9% SODIUM CHLORIDE INJECTION, USP
• Manufacturer (Section D): EXCELSIOR MEDICAL LLC; 1933 heck ave.; neptune NJ 07753
• Manufacturer (Section G): EXCELSIOR MEDICAL LLC; 1933 heck ave.; neptune NJ 07753
• Manufacturer Contact: john linfante ; 1933 heck ave.; neptune, NJ 07753 ; 7326436088
• MDR Report Key: 5616850
• MDR Text Key: 43986133
• Report Number: 2027791-2016-00001
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142620
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: 1011-240
• Device Lot Number: 3126312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1