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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP CONVENTIONAL SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP CONVENTIONAL SYRINGE Back to Search Results
Catalog Number 309657
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)
Patient Problem Blurred Vision (2137)
Event Date 01/16/2018
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone#: (b)(6). 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 before use, a bd luer-lok¿ disposable syringe with bd luer-lok¿ tip was found with volumetric inaccuracy as ¿the graduated lines on the syringe were blurry, illegible and inaccurate. ¿ there was no report of injury or medical intervention reported.
 
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Brand NameBD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
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 Key7311269
MDR Text Key101487112
Report Number1213809-2018-00081
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096573
UDI-Public30382903096573
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2022
Device Catalogue Number309657
Device Lot Number7267924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2017
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: 03/02/2018 Patient Sequence Number: 1
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