• 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¿ SYRINGE WITH ATTACHED NEEDLE; 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¿ SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 309571
Device Problem Missing Information (4053)
Patient Problem Insufficient Information (4580)
Event Date 09/06/2023
Event Type  malfunction  
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.The customer's address is unknown.Virginia, usa has been used as a placeholder based on the reported phone area code.H.3.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 3 bd luer-lok¿ syringes with attached needle had no lot/expiration date on their labeling.The following information was provided by the initial reporter: "we have received and discovered an additional three cases that did not have the secondary barcode along with the lot/expiration date on the label.".
 
Manufacturer Narrative
H6: investigation summary: one photo of a 3ml luer-lock syringe box carton was received and evaluated.The image shows two box cartons, both having box labels on the carton with one label having all applicable product information and the other label missing the secondary bar code, batch number and expiration date.The condition observed is non-conforming per product specification.Potential root cause for the label content missing defect is associated with the packaging process.As corrective actions, quality alert will be issued to manufacturing facility and re-education will be provided to all operators associated with production batch.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
 
Event Description
It was reported that 3 bd luer-lok¿ syringes with attached needle had no lot/expiration date on their labeling.The following information was provided by the initial reporter: "we have received and discovered an additional three cases that did not have the secondary barcode along with the lot/expiration date on the label.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
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
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17795517
MDR Text Key324022170
Report Number1213809-2023-01054
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 10/12/2023
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 Number309571
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/06/2023
Initial Date FDA Received09/21/2023
Supplement Dates Manufacturer Received10/12/2023
Supplement Dates FDA Received10/19/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-