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 AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
  • 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 AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320574
Device Problem Failure to Deliver (2338)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 10/06/2023
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.Unknown, new jersey, 00000 usa has been used as a default.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 the bd nano¿ 2nd gen pen needle was difficult to operate.The following was received from the initial reporter: at the very tip of the needle there is more plastic.She said she is getting a bubble in the skin now with this needle and would like to know if there has been a change in them.Hello.I am writing because i received a new shipment of bd 0.23mm x 4mm 32g x 5/32¿ needles from optum rx a few days ago.I was diagnosed late in life with type 1 diabetes 10 years ago, and i have been using bd needles ever since.Bd is clearly the preference of my endocrinologist.I noticed that there is a change in the needles near the tip - more plastic.The needle size is of course the same, but it seems a little more difficult to inject the insulin.
 
Event Description
It was reported that the bd nano¿ 2nd gen pen needle was difficult to operate.The following was received from the initial reporter: at the very tip of the needle there is more plastic.She said she is getting a bubble in the skin now with this needle and would like to know if there has been a change in them.Hello.I am writing because i received a new shipment of bd 0.23mm x 4mm 32g x 5/32¿ needles from optum rx a few days ago.I was diagnosed late in life with type 1 diabetes 10 years ago, and i have been using bd needles ever since.Bd is clearly the preference of my endocrinologist.I noticed that there is a change in the needles near the tip - more plastic.The needle size is of course the same, but it seems a little more difficult to inject the insulin.
 
Manufacturer Narrative
The following fields were updated due to correction:: correction made to imdrf annex b grid: from b001-testing of actual suspected to device to b15-analysis of data provided by user/third party.
 
Event Description
It was reported that the bd nano¿ 2nd gen pen needle was difficult to operate.The following was received from the initial reporter: at the very tip of the needle there is more plastic.She said she is getting a bubble in the skin now with this needle and would like to know if there has been a change in them.Hello.I am writing because i received a new shipment of bd 0.23mm x 4mm 32g x 5/32¿ needles from optum rx a few days ago.I was diagnosed late in life with type 1 diabetes 10 years ago, and i have been using bd needles ever since.Bd is clearly the preference of my endocrinologist.I noticed that there is a change in the needles near the tip - more plastic.The needle size is of course the same, but it seems a little more difficult to inject the insulin.
 
Manufacturer Narrative
H.6.Investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was not able to confirm the customer-indicated issue.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.H3 other text : see h.10.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD NANO¿ 2ND GEN PEN NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer (Section G)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17936616
MDR Text Key325688519
Report Number9616656-2023-01102
Device Sequence Number1
Product Code FMI
UDI-Device Identifier00382903205745
UDI-Public(01)00382903205745
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 Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number320574
Device Lot Number2333543
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-