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¿ ORAL DISPENSING SYRINGE; LIQUID MEDICATION DISPENSER
  • 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¿ ORAL DISPENSING SYRINGE; LIQUID MEDICATION DISPENSER Back to Search Results
Model Number 305853
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/27/2022
Event Type  malfunction  
Event Description
It was reported that 8 bd¿ oral dispensing syringe was discovered to be without label markers.The following information was provided by the initial reporter: 3mls oral syringe has no label markers on the syringe.At least 8 from the batch has no labeling.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval: yes; d.10.Returned to manufacturer on: 06-sep-2022.H.6.Investigation summary: one sample and four photos were provided to our quality team for investigation.Through visual inspection, it was observed that the barrel is blank and missing all its scale markings.Potential root cause for the missing print defect is associated with the printer process.These conditions are occurring below their expected frequency so no corrective action is required at this time.A device history record review was completed for provided lot number 9177777.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
 
Event Description
It was reported that 8 bd¿ oral dispensing syringe was discovered to be without label markers.The following information was provided by the initial reporter: 3mls oral syringe has no label markers on the syringe.At least 8 from the batch has no labeling.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD¿ ORAL DISPENSING SYRINGE
Type of Device
LIQUID MEDICATION DISPENSER
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 Key15250121
MDR Text Key304837000
Report Number1213809-2022-00509
Device Sequence Number1
Product Code KNT
UDI-Device Identifier30382903058533
UDI-Public30382903058533
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K112434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number305853
Device Catalogue Number305853
Device Lot Number9177777
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-