MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 60 ML SYRINGE LUER LOCK; SYRINGE, PISTON

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  Injury  

Event Description

Situation was staff was drawing up sodium chloride in a bd 60 cc syringe luer lock.When staff went to insert the sodium chloride, the bottom of the inside of the syringe came apart.There was black residue from the inside of the plunger.Pt was not affected as we were prepping and then noticed.Midas report was filed with sutter.Fda safety report id# (b)(4).

• Brand Name: BD 60 ML SYRINGE LUER LOCK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 8556657
• MDR Text Key: 143434585
• Report Number: MW5086222
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention