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U.S. Department of Health and Human Services

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

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BECTON DICKINSON AND COMPANY BD¿ SYRINGE WITH BD LUER-LOK¿ TIP PISTON SYRINGE Back to Search Results
Catalog Number 309653
Device Problem Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). Fda notified: the initial reporter also notified the fda on 06/25/2018 via medwatch # mw5077814. 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 via medwatch that the bd¿ syringe with bd luer-lok¿ tip syringe was found to have excess lubricant. There was no report of exposure, serious injury or medical intervention.
 
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Brand NameBD¿ SYRINGE WITH BD 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
8015652845
MDR Report Key7698981
MDR Text Key114681863
Report Number1911916-2018-00378
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
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309653
Device Lot Number8054766
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2018
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: 07/18/2018 Patient Sequence Number: 1
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