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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿ CONVENTIONAL SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿ CONVENTIONAL SYRINGE Back to Search Results
Catalog Number 309643
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that during use of the bd syringe with hypodermic needle precisionglide¿ there was an issue with foreign matter on the top of the syringe.
 
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Brand NameBD SYRINGE WITH HYPODERMIC NEEDLE PRECISIONGLIDE¿
Type of DeviceCONVENTIONAL SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key8203788
MDR Text Key131712413
Report Number1213809-2018-00935
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeLE
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309643
Device Lot Number7335909
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 Received12/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2017
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: 12/28/2018 Patient Sequence Number: 1
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