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¿ AMBER ORAL SYRINGE WITH NON LUER TIP, 3 ML; 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¿ AMBER ORAL SYRINGE WITH NON LUER TIP, 3 ML; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305210
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2023
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd¿ amber oral syringe with non luer tip, 3 ml there were mixed products in the pack.There was no report of patient impact.The following information was provided by the initial reporter: a different model of syringe found within amber oral syringe lot 1082858.
 
Manufacturer Narrative
H6: investigation summary two photos were provided to our quality team for investigation.Based on the investigation and with the returned photo sample analysis the symptom reported is confirmed.Potential root cause for the mixed product defect is associated with inadequate line clearance in the packaging process.A device history record review was completed for provided lot number 1082858.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.
 
Event Description
It was reported while using bd¿ amber oral syringe with non luer tip, 3 ml there were mixed products in the pack.There was no report of patient impact.The following information was provided by the initial reporter: a different model of syringe found within amber oral syringe lot 1082858.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD¿ AMBER ORAL SYRINGE WITH NON LUER TIP, 3 ML
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 Key16219855
MDR Text Key308378137
Report Number1213809-2023-00022
Device Sequence Number1
Product Code KYW
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
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 02/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305210
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/23/2023
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
-
-