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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. SYRINGES 60ML

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BECTON DICKINSON AND CO. SYRINGES 60ML Back to Search Results
Device Problems Fluid Leak (1250); Product Quality Problem (1506); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Other  
Event Description
Fluid is getting beyond the entire black rubber of the bd iv syringes of many different sizes. We have been actively reporting this to bd since 2016. Some of the feedback from the quality systems specialist at bd confirmed the leaking and has indicated that there is a project to address the leakage issues which is associated with the barrel design. Syringes sizes we have reported to have leakage is 60 ml, 10 ml, 30 ml, 20 ml, and 5 ml. Bd has informed us that if the fluid gets beyond the first part of the black rubber plunger, the medication is not compromised but if it goes beyond the entire black rubber, the sterility is breached. Our staff save the syringes and report the lot number to me when they see it. I'm unsure how many go undetected. I'm reporting to make others aware that a sterility breach may go undetected. I'ts difficult to see with the bare naked eye. Medication not administered to or used by the patient. Patient counselling provided: is unknown. (b)(4).
 
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Brand NameSYRINGES 60ML
Type of DeviceSYRINGES 60ML
Manufacturer (Section D)
BECTON DICKINSON AND CO.
MDR Report Key6154472
MDR Text Key62335766
Report NumberMW5066580
Device Sequence Number1
Product Code FMF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 09/02/2016
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received12/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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