MAUDE Adverse Event Report: COVIDIEN MONOJECT 0.9% SODIUM CHLORIDE FLUSH SYRINGE 10ML

Lot Number 14A0174

Device Problem Incorrect Device Or Component Shipped (2962)

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

Event Date 06/09/2014

Event Type  malfunction  

Event Description

Five ml syringes were found inside of a box of covidien monoject 0.9 percent sodium chloride flush syringe 10 ml.Lot # 14a0174, exp: 12/2015.

• Brand Name: MONOJECT 0.9% SODIUM CHLORIDE FLUSH SYRINGE 10ML
• Type of Device: SODIUM CHLORIDE FLUSH
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 3874098
• MDR Text Key: 4571453
• Report Number: MW5036583
• Device Sequence Number: 1
• Product Code: NGT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2014

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 Expiration Date: 12/01/2015
• Device Lot Number: 14A0174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/10/2014
• Patient Sequence Number: 1