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 DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 32G 4MM PRO 90CT US; Needle, hypodermic, single lumen
  • 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 DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 32G 4MM PRO 90CT US; Needle, hypodermic, single lumen Back to Search Results
Model Number 320574
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2024
Event Type  malfunction  
Event Description
Consumer reported had 1 needle break off during injection.Cannot locate the needle on floor.Nor also the site.Denied reuse of needless.Has not seen medical attention - but might visit his er.Event date today 02.23.2024 - dc lot # 2200715.Catalog# 320574.Date of event 02.23.2024.Sample status discard.Cs0070082.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PEN NDL 32G 4MM PRO 90CT US
Type of Device
Needle, hypodermic, single lumen
Manufacturer (Section D)
BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
Manufacturer (Section G)
BECTON DICKINSON AND CO.
1 becton drive
franklin lakes, NJ 07417
Manufacturer Contact
avital merl
300 kimball dr.
parsippany, NJ 07054
MDR Report Key18948774
MDR Text Key338988106
Report Number9616656-2024-05164
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903205745
UDI-Public00382903205745
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K212015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/21/2024
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 Lay User/Patient
Device Model Number320574
Device Lot Number2200715
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/23/2024
Initial Date FDA Received03/21/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/19/2022
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
-
-