MAUDE Adverse Event Report: EXCELSIOR MEDICAL 91419 FLUSH SYRINGE 10 10 SALINE; PRE-FILL SALINE SYRINGE

Model Number 8881579121

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  Other  

Event Description

It was reported to covidien on (b)(6) 2013 that a customer had an issue with a pre-fill saline syringe.The customer reports that they recently had a 10ml 0.9% saline flush syringe found to be filled with air.It was sealed in the bag and started to be injected in the pt when the tech noticed it was filled with air, not saline solution.It was still at the 10 ml mark.

Manufacturer Narrative

An investigation is currently underway; upon completion, the results will be forwarded.

• Brand Name: 91419 FLUSH SYRINGE 10 10 SALINE
• Type of Device: PRE-FILL SALINE SYRINGE
• Manufacturer (Section D): EXCELSIOR MEDICAL; 1933 heck avenue; neptune NJ 07753
• Manufacturer (Section G): EXCELSIOR MEDICAL; 1933 heck ave.; neptune NJ 07753
• Manufacturer Contact: elaine bishop ; 15 hampshire st.; mansfield, MA 02048 ; 5084524686
• MDR Report Key: 3581679
• MDR Text Key: 16548435
• Report Number: 1282497-2014-00004
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2013

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 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?: Yes
• Initial Date Manufacturer Received: 12/20/2013
• Initial Date FDA Received: 01/10/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1