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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50-60ML L/L NO NEEDL SYRINGE, PISTON

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BECTON DICKINSON SYRINGE 50-60ML L/L NO NEEDL SYRINGE, PISTON Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Injury  
Event Description
Patient reports that she has been sick or had an infection (symptoms/ further details not reported). Md is aware. She also states i have had two barrel syringes start leaking. I've had to transfer the medicine to new syringes both times. No missed dose reported. No side effects reported. Unknown if leaky syringes on hand for return to the manufacturer, lot not provided. Reported (b)(6) by pt/caregiver.
 
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Brand NameSYRINGE 50-60ML L/L NO NEEDL
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key11337416
MDR Text Key232352637
Report NumberMW5099409
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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