MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT; ENTERAL SYRINGE, SPECIFIC

Model Number 8881135015

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/28/2019

Event Type  Injury  

Event Description

A 35 ml enteral feeding syringe was taken from stock to be used to feed a nicu baby.Upon inspection of the syringe, a jagged piece of plastic was seen inside the unused syringe.The 35 ml syringe that was being used had a1 on top of the syringe.The piece of plastic within the syringe appears to be a broken edge of a top of a syringe and has an a8 on top of it.Manufacturer's response per hospital reporter.Covidien stated that this device is now part of cardinal health as of july 28, 2018.

• Brand Name: MONOJECT
• Type of Device: ENTERAL SYRINGE, SPECIFIC
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 785 fort mill hwy.; fort mill SC 29707
• MDR Report Key: 8319762
• MDR Text Key: 135517411
• Report Number: 8319762
• Device Sequence Number: 1
• Product Code: PNR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881135015
• Device Catalogue Number: 8881135015
• Device Lot Number: 631958
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1