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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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Brand NameBD SYRINGES
Type of DeviceBD SYRINGES
Manufacturer (Section D)
BD
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
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