MAUDE Adverse Event Report: SYRINGE FLUSH; SALINE, VASCULAR, ACCESS FLUSH

Device Problem Device Emits Odor (1425)

Patient Problem Irritation (1941)

Event Date 08/02/2017

Event Type  Injury  

Event Description

Nurse switched to prepackaged saline solution when flushing my venous line at completion of dialysis.I immediately sensed something different as i don't "taste" saline.This product irritated my throat and sinuses immediately.It had an unusual smell in my nose, also.It was a chemical taste and odor.This did not happen previously withdrawn saline.Frequency: once a day, route: into a vein.Dates of use: (b)(6) 2017.Diagnosis or reason for use: flushing a venous line."is the product over-the-counter: no; is the product compounded: no; event abated after use stopped or dose reduced: yes; event reappeared after reintroduced: yes.".

• Brand Name: SYRINGE FLUSH
• Type of Device: SALINE, VASCULAR, ACCESS FLUSH
• MDR Report Key: 6767308
• MDR Text Key: 81923342
• Report Number: MW5071380
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2017
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 112