MAUDE Adverse Event Report: EXCELSIOR MEDICAL 10ML IN 10ML SALINE FLUSH; 0.9% SALINE CHLORIDE INJECTION, USP

Model Number EM-3513576

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

On (b)(6) 2014, it was reported to excelsior that the luer slip (or tip) of the syringe product was dirty.The affected syringe was reportedly not used on a patient.

Manufacturer Narrative

Excelsior is currently conducting an investigation regarding the reported issue.Preliminary results of the investigation are as follows: production records of the affected lot were reviewed and found to contain no issues that could have caused or contributed to the reported event.Retention samples from the affected lot were visually inspected for the reported issue and, no defects were found.Retention samples from other finished lots made with the same syringe raw material were also visually inspected for the reported malfunction, and no defects were found.The complaint syringe was subjected to analytical testing by a third-party laboratory.Fourier transform infrared (ftir) spectroscopy, performed on the complaint syringe, showed matches to silicone and fatty acid amides.Medical grade silicone is used as a lubricant for the syringe barrel and piston.An overall analysis of excelsior's filling process is being finalized.In addition, the syringe supplier is also conducting an investigation into the reported issue.All information associated with this event will be reviewed by excelsior's medical director for a clinical assessment.Upon completion on this investigation, a follow-up report will be filed.It is important to note that the reported malfunction was identified prior to use.The syringe was not used on a patient.Therefore, there is no health impact associated with this event.Out of an abundance of caution, excelsior is filing this event at this time.

Manufacturer Narrative

An overall analysis 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.The syringe supplier conducted an investigation into the reported issue, but could not identify a cause for the reported contamination.A clinical assessment performed by (b)(4), dr.(b)(6), found that the particles would have no clinical effect if the subject syringe had been used on a patient.Based on the investigation, 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 3119586.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 march 2015.Excelsior has opened correction action, (b)(4), to track the progress of the supplier's installation of the automated inspection system.

• Brand Name: 10ML IN 10ML SALINE FLUSH
• Type of Device: 0.9% SALINE CHLORIDE INJECTION, USP
• Manufacturer (Section D): EXCELSIOR MEDICAL; 1933 heck avenue; neptune nj 07753
• Manufacturer (Section G): EXCELSIOR MEDICAL; 1933 heck avenue; neptune NJ 07753
• Manufacturer Contact: john linfante ; 1933 heck avenue; neptune, NJ 07753 ; 7326436088
• MDR Report Key: 4105852
• MDR Text Key: 4716924
• Report Number: 2027791-2014-00003
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K962938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Type of Report: Initial,Followup
• Report Date: 11/29/2014

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: Other
• Device Expiration Date: 03/01/2016
• Device Model Number: EM-3513576
• Device Lot Number: 3119586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2014
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2014
• 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