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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE

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BECTON DICKINSON AND COMPANY BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE Back to Search Results
Catalog Number 309653
Device Problems Leak/Splash (1354); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a bd 60ml syringe luer-lok¿ tip did not seal properly between the plunger and barrel and leaked. The report is as follows, "the pharmacy is reporting that a 60ml syringe they are using to draw up medications are not sealing properly between the plunger and barrel of the syringe. This is causing the medication to leak past the plunger. ".
 
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Brand NameBD 60ML SYRINGE LUER-LOK TIP
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON AND COMPANY
2153 12th avenue
columbus NE 68601
Manufacturer (Section G)
BECTON DICKINSON AND COMPANY
2153 12th avenue
columbus NE 68601
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8391986
MDR Text Key138082992
Report Number1911916-2019-00239
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309653
Device Lot Number8270800
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
Date Manufacturer Received02/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/05/2019 Patient Sequence Number: 1
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