Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 AND COMPANY BD LUER-LOK; SYRINGE, PISTON
  • 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 AND COMPANY BD LUER-LOK; SYRINGE, PISTON Back to Search Results
Model Number 309657
Device Problems Fluid/Blood Leak (1250); Defective Device (2588); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/07/2022
Event Type  malfunction  
Event Description
As per report, "nurse began drawing up methylprednisolone and medication began spilling out of back end of syringe.When problem was realized, nurse looked at syringe and found that the black rubber plunger/stopper in 3ml syringe appears malformed." manufacturer response for 3ml syringe, (brand not provided) (per site reporter) sales rep reported issue to manufacturer.Bd has requested additional information and the product back for follow-up.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD LUER-LOK
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BECTON, DICKINSON AND COMPANY
1 becton dr
franklin lakes NJ 07417
MDR Report Key16085694
MDR Text Key306526136
Report Number16085694
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number309657
Device Catalogue Number309657
Device Lot Number1357028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/14/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/13/2022
Event Location Hospital
Date Report to Manufacturer01/03/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-