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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON LUER-LOK; SYRINGE, PISTON

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BECTON DICKINSON LUER-LOK; SYRINGE, PISTON Back to Search Results
Lot Number 0098739
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  malfunction  
Event Description
The packaging of this 20ml luer lock syringe splits and rips when attempting to open and deliver the device to the sterile surgical field, contaminating the syringe.This is a sterile product however packaging does not allow the product to be removed in a way that maintains sterility.
 
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Brand Name
LUER-LOK
Type of Device
SYRINGE, PISTON
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key11588329
MDR Text Key242994337
Report Number11588329
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 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number0098739
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/19/2021
Event Location Hospital
Date Report to Manufacturer03/30/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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