MAUDE Adverse Event Report: BD 10CC BD SYRINGE

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Split (2537)

Patient Problem Injury (2348)

Event Date 07/07/2017

Event Type  malfunction  

Event Description

On (b)(6)2017 - during a neuro procedure a 10cc bd syringe split while injecting contrast.The syringe sprayed neuro doctor with blood and contrast, and also sprayed the staff with blood and contrast - have in my possession.

• Brand Name: 10CC BD SYRINGE
• Type of Device: 10CC BD SYRINGE
• Manufacturer (Section D): BD
• MDR Report Key: 6718087
• MDR Text Key: 80192303
• Report Number: MW5071022
• 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: Patient
• Type of Report: Initial
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other