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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE ++ 1ML L/L NO NEEDL BD SYRINGE, PISTON

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BECTON DICKINSON SYRINGE ++ 1ML L/L NO NEEDL BD SYRINGE, PISTON Back to Search Results
Device Problems Leak/Splash (1354); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Indication: systemic involvement of connective tissue unspecified. Event: patient reported that last time he received shipment the syringe the nurse used to draw up medication from single dose vial was defective and medication leaked out of syringe. Dose was missed. No adverse event reported. Product not available for return. Lot number and expiration unknown. Outcome: reship for missed dose sent. No additional information provided. Syringe used for rx ilaris sdv 150mg/ml inject 150 mg under the skin every month. Reported to (b)(6) by pt/caregiver.
 
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Brand NameSYRINGE ++ 1ML L/L NO NEEDL BD
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
MDR Report Key12467303
MDR Text Key271640340
Report NumberMW5103909
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 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
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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