MAUDE Adverse Event Report: BD BD POSTFLUSH

Model Number 8290-306546

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

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

Event Date 12/15/2016

Event Type  malfunction  

Event Description

Foreign body noted to be floating in the saline of a 10cc pre filled syringe.Dose or amount: 10 ml.

• Brand Name: BD POSTFLUSH
• Type of Device: POSTFLUSH
• Manufacturer (Section D): BD; franklin lakes NJ 07417
• MDR Report Key: 6215333
• MDR Text Key: 63705559
• Report Number: MW5066991
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 8290-306546
• Device Lot Number: 6270730
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other