MAUDE Adverse Event Report: HOSPIRA, INC. IV SOLUTIONS; FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE

Lot Number 95-708-FW

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2019

Event Type  malfunction  

Event Description

1 bag of 500 ml normal saline was found to have an unknown substance on the bottom of the bag near the iv port.

• Brand Name: IV SOLUTIONS
• Type of Device: FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
• Manufacturer (Section D): HOSPIRA, INC.; 375 n. field dr.; lake forest IL 60045
• MDR Report Key: 9082091
• MDR Text Key: 159011914
• Report Number: 9082091
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/14/2019

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: No Information
• Device Lot Number: 95-708-FW
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1