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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON & CO. BD 50 ML SYRINGE, LUER-LOK TIP SYRINGE, PISTON

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BECTON DICKINSON & CO. BD 50 ML SYRINGE, LUER-LOK TIP SYRINGE, PISTON Back to Search Results
Lot Number 0170292
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2020
Event Type  malfunction  
Event Description
Bd 60 cc syringes leak medicine around the plunger. Allows medicine to leak/loss of meds. Possible inaccurate dosing. Fda safety report id# (b)(4).
 
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Brand NameBD 50 ML SYRINGE, LUER-LOK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON & CO.
MDR Report Key10747716
MDR Text Key213672238
Report NumberMW5097485
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0170292
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/27/2020 Patient Sequence Number: 1
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