MAUDE Adverse Event Report: ICU MEDICAL, INC 0.9% SODIUM CHLORIDE INJECTION; 0.9% SODIUM CHLORIDE INJECTION, USP, 1000 ML

Model Number NDC0990-7983-09

Device Problem Missing Information (4053)

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

Event Date 02/10/2021

Event Type  malfunction  

Event Description

Rn opened bag of normal saline to administer to patient.Rn went to scan bag of iv fluids and noticed there was no barcode on the bag to scan within epic.

• Brand Name: 0.9% SODIUM CHLORIDE INJECTION
• Type of Device: 0.9% SODIUM CHLORIDE INJECTION, USP, 1000 ML
• Manufacturer (Section D): ICU MEDICAL, INC; 600 n field dr; lake forest IL 60045
• MDR Report Key: 11371999
• MDR Text Key: 233276227
• Report Number: 11371999
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NDC0990-7983-09
• Device Catalogue Number: NDC0990-7983-09
• Device Lot Number: 4897324
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4015 DA
• Patient Weight: 49