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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD PLASTIPAK SYRINGE, PISTON

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD PLASTIPAK SYRINGE, PISTON Back to Search Results
Model Number 309657
Device Problem Contamination (1120)
Patient Problem Insufficient Information (4580)
Event Date 03/31/2021
Event Type  malfunction  
Event Description
A 3ml syringe removed from med room along with an 18g needle to draw up a medication for administering iv. Just before inserting the needle noticed issue with the syringe. Upon further inspection it was noted that there was some kind of sticky substance in the syringe. Needle had not been inserted into the vial yet, unsure where this substance came from. Fda safety report id# (b)(4).
 
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Brand NameBD PLASTIPAK
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
MDR Report Key11618786
MDR Text Key244193670
Report NumberMW5100562
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 04/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number309657
Device Catalogue Number309657
Device Lot Number1041512
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

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