• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE HYPODERMIC SYRINGE Back to Search Results
Catalog Number 309628
Device Problem Unintended Movement (3026)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation results: summary: one open 1ml packaged syringe was received and confirmed to be from batch #7271993, ((b)(4)). The sample was visually evaluated. The syringe has no visual defects. The plunger function was also performed. No defects were observed, the syringe functioned as expected. The 1ml ll product does not have a retaining ring by design according to its product specification. Dhr review is not required due to the complaint being for the design of the product and not a true defect. The design of the product has not changed since october 2008 when the product was first introduced. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Root cause: root cause and capa not required as no defects were confirmed.
 
Event Description
It was reported that difficult plunger movement occurred while using a bd luer-lok¿ disposable syringe, as the customer stated "no stop in syringe plunger when pulling back. " there was no report of exposure, serious injury, or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD LUER-LOK¿ DISPOSABLE SYRINGE
Type of DeviceHYPODERMIC 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 Key7574628
MDR Text Key110649325
Report Number1213809-2018-00324
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSW
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 06/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309628
Device Lot Number7271993
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/25/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/20/2017
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: 06/06/2018 Patient Sequence Number: 1
-
-