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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 10 ML SYRINGE LUER-LOK TIP SYRINGE, PISTON

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BECTON DICKINSON AND COMPANY BD 10 ML SYRINGE LUER-LOK TIP SYRINGE, PISTON Back to Search Results
Lot Number 9273092
Device Problems Contamination (1120); Crack (1135); Leak/Splash (1354); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 11/24/2020
Event Type  malfunction  
Event Description
After compounding a radiopharmaceutical, the isotope was drawn up into a bd10ml syringe, punctured the rubber stopper of the vial and pressed the plunger of the syringe. The syringe had a crack in the barrel which the radioactive isotope squirted out of and contaminated the inside of the caci hood. Our nuclear medicine department has found numerous defective syringes ranging from 3 ml, 5 ml, and 10 ml sizes. This is the first time one has produced a contamination of equipment or personal. Fda safety report id#: (b)(4).
 
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Brand NameBD 10 ML SYRINGE LUER-LOK TIP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
MDR Report Key11574372
MDR Text Key242753652
Report NumberMW5100281
Device Sequence Number1
Product Code FMF
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number9273092
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?
Type of Device Usage

Patient Treatment Data
Date Received: 03/25/2021 Patient Sequence Number: 1
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