MAUDE Adverse Event Report: EXCELSIOR MEDICAL CORPORATION OMNIFLUSH SYRINGE10ML 0.9% SODIUM CHLORIDE (NACL); 0.9% SODIUM CHLORIDE INJECTION, USP

Model Number EM-3513576

Device Problems Contamination (1120); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

One of excelsior's (b)(4) reported that a contamination was detected in the syringe.According to the report, the contamination was dark particles in the saline solution and under the white cap at the locking point of the syringe.It should be noted that the syringe was not used on the patient.A review of the original report to excelsior concluded that a medical device report was not required.However, excelsior's distributor filed an initial vigilance report with the (b)(6), excelsior was made aware of the filing on (b)(4) 2014.As a result, excelsior filed a final vigilance report with (b)(4) on (b)(4) 2014.As a result excelsior is now filing this report with the fda.

Manufacturer Narrative

Production records for lot 3119062 were reviewed and found to contain no issues that could have caused or contributed to the reported contamination.The subject complaint device was returned to excelsior for evaluation.Visual examination of the complaint syringe confirmed the reported particles in the syringe barrel and white tip cap openings.Retention samples from lot 3119062 were visually inspected and found to contain no defects.Similarly, retention samples from other finished products made with the same syringe and tip cap raw materials were visually examined; no defects were identified during this inspection.Analytical testing on the complaint device was performed by an outside laboratory.The testing identified inorganic and organic materials including carbon, oxygen, sodium, silicone, chlorine, barium and iron.It should be noted that the presence of sodium, chlorine and oxygen is to be expected in the saline solution.The presence of silicone, carbon and oxygen is also to be expected because silicone fluid is used as the lubricant for the syringe barrel wall and rubber piston.A clinical assessment performed by excelsior's medical director, (b)(4), found that the particles would cause no clinical harm in the unlikely event that the particles were injected into the patient.An evaluation of excelsior's incoming raw material inspection and syringe filling processes found that the reported contamination most likely did not occur during processing at excelsior medical.An investigation conducted by the tip cap supplier found that the reported contamination most likely did not occur during processing of the particular tip cap lot.The syringe supplier conducted an investigation into the reported issue, but could not identify a cause for the reported contamination.Based on the above assessments, excelsior could not identify a definitive root cause for the reported event.The reported issue appears to be an isolated incident, with this report being the only event for lot 3119062.Excelsior utilizes automated inspection systems to detect several attributes including foreign matter during production.Faulty syringes detected by the automated inspection systems are rejected during processing.In addition, the syringe supplier is currently working on implementing an automated inspection system during the assembly process of the syringe barrels.The expected implementation date at the syringe supplier is (b)(4) 2015.

• Brand Name: OMNIFLUSH SYRINGE10ML 0.9% SODIUM CHLORIDE (NACL)
• Type of Device: 0.9% SODIUM CHLORIDE INJECTION, USP
• Manufacturer (Section D): EXCELSIOR MEDICAL CORPORATION; 1933 heck avenue; neptune NJ 07753
• Manufacturer (Section G): EXCELSIOR MEDICAL CORPORATION; 1933 heck avenue; neptune NJ 07753
• Manufacturer Contact: john linfante ; 1933 heck avenue; neptune, NJ 07753 ; 7326436088
• MDR Report Key: 4219580
• MDR Text Key: 4974955
• Report Number: 2027791-2014-00004
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K962938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: EM-3513576
• Device Lot Number: 3119062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2014
• 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