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 MEDICAL SYSTEMS BD LUER-LOK¿ TIP SYRINGE; PISTON 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¿ TIP SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 301029
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2022
Event Type  malfunction  
Manufacturer Narrative
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 when using the bd luer-lok¿ syringe, the device experienced crack on the side of the barrel and a leak.This event occurred 75 times.The following information was provided by the initial reporter.The customer stated: it was reported crack over the tank side of the syringe.Crack over the tank side of the syringe.Issue - a crack over the tank side of the syringe.
 
Manufacturer Narrative
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 when using the bd luer-lok¿ syringe, the device experienced crack on the side of the barrel and a leak.This event occurred 75 times.The following information was provided by the initial reporter.The customer stated: it was reported crack over the tank side of the syringe.Crack over the tank side of the syringe.Issue - a crack over the tank side of the syringe.
 
Event Description
It was reported when using the bd luer-lok¿ syringe, the device experienced crack on the side of the barrel and a leak.This event occurred 75 times.The following information was provided by the initial reporter.The customer stated: it was reported crack over the tank side of the syringe crack over the tank side of the syringe.Issue - a crack over the tank side of the syringe.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes, d10: returned to manufacturer on: 24-mar-2022.Investigation summary: one sample and four photos of 10ml syringes were received.Through visual inspection, it is observed that the sample has a crack from the 1.5ml area to the 7.5ml area from the outside of the barrel.The condition observed was non-conforming per product specification.Potential root cause for the cracked barrel defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch 1111287 is considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD LUER-LOK¿ TIP SYRINGE
Type of Device
PISTON 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13535684
MDR Text Key285679501
Report Number1213809-2022-00072
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,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/04/2022
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 Other
Device Catalogue Number301029
Device Lot Number1111287
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2022
Initial Date FDA Received02/15/2022
Supplement Dates Manufacturer Received04/04/2022
Supplement Dates FDA Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-