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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD SYRINGES

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BD BD SYRINGES Back to Search Results
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.
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Type of DeviceBD SYRINGES
Manufacturer (Section D)
MDR Report Key6562835
MDR Text Key75147109
Report NumberMW5069724
Device Sequence Number1
Product Code FMF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
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 Received05/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/05/2021
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 05/10/2017 Patient Sequence Number: 1