MAUDE Adverse Event Report: EXCELSIOR MEDICAL LLC SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH

Model Number EMZED10001

Device Problems Device Emits Odor (1425); Material Opacification (1426)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2020

Event Type  No Answer Provided  

Event Description

Rn was doing morning meds and pulled a saline flush to give and noticed that it appeared cloudy.She then compared it to another flush (different lot number) and confirmed that it was indeed cloudy.Per discussion with nursing staff the fluid in the saline flush had a "strong chemical smell.".

• Brand Name: SALINE FLUSH
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): EXCELSIOR MEDICAL LLC; 317 fairfield road; freehold NJ 07728
• MDR Report Key: 10940558
• MDR Text Key: 219351935
• Report Number: 10940558
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/02/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: EMZED10001
• Device Lot Number: 2007079
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/02/2020
• Event Location: Other
• Date Report to Manufacturer: 12/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1