MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD POSIFLUSH (3ML NS FLUSH); SALINE, VASCULAR ACCESS FLUSH

Lot Number 0203206

Device Problem Contamination (1120)

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

Event Date 12/14/2020

Event Type  malfunction  

Event Description

Pink substance on syringe hub.Product name and/ or catalog number: bd posiflush (3ml ns flush).Lot number or serial number: (b)(4).

• Brand Name: BD POSIFLUSH (3ML NS FLUSH)
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 11036879
• MDR Text Key: 222762839
• Report Number: MW5098446
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 02023000630
• UDI-Public: 02023-0006-30
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0203206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1