MAUDE Adverse Event Report: BD BD SYRINGES

Device Problem Leak/Splash (1354)

Patient Problems Dyspnea (1816); Rash (2033)

Event Date 05/02/2017

Event Type  Injury  

Event Description

The stoppers of bd syringe leaks and causes rashes and difficulty breathing from the chemical composition of the stopper.

• Brand Name: BD SYRINGES
• Type of Device: BD SYRINGES
• Manufacturer (Section D): BD
• MDR Report Key: 6562835
• MDR Text Key: 75147109
• Report Number: MW5069724
• Device Sequence Number: 1
• Product Code: FMF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/05/2021
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability