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

Model Number 8881579121

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

On (b)(6) 2014, it was reported to excelsior that a recently received 10ml 0.9% saline flush was filled with air.The subject syringe was sealed in the bag [overwrap plastic].When injection into the patient began, the tech noticed that it was filled with air, not saline solution.It was still at the 10ml mark.When the tech realized that the syringe was just air, she stopped and used another syringe to pull back the air in the tube.No medical intervention was needed; the patient was not harmed.

Manufacturer Narrative

Excelsior is currently investigating the reported issue.Production records of the affected lot will be reviewed as part of this investigation.The subject syringe will also be evaluated if it is returned to excelsior.In addition, all information associated with this event will be reviewed by excelsior's medical director.Upon completion of this investigation, a follow-up report will be filed.

• Brand Name: 10 IN A 10ML SALINE FLUSH
• Type of Device: 0.9% SODIUM 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: 3606975
• MDR Text Key: 4092382
• Report Number: 2027791-2014-00002
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/04/2014

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: 03/01/2015
• Device Model Number: 8881579121
• Device Catalogue Number: 8881579121
• Device Lot Number: 12-002-CV
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2014
• Initial Date FDA Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/05/2013
• 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