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¿ PRO ULTRA-FINE¿ 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¿ PRO ULTRA-FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 320555
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2022
Event Type  malfunction  
Event Description
It was reported that 40 bd nano¿ pro ultra-fine¿ pen needles experienced their outer covers being unable to attach to the pen needle to remove it from the pen.The following information was provided by the initial reporter: consumer reported finding about 40 pen needles with the outer cover unable to attach to pen needle to remove from pen.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: no samples were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
 
Event Description
It was reported that 40 bd nano¿ pro ultra-fine¿ pen needles experienced their outer covers being unable to attach to the pen needle to remove it from the pen.The following information was provided by the initial reporter: consumer reported finding about 40 pen needles with the outer cover unable to attach to pen needle to remove from pen.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD NANO¿ PRO ULTRA-FINE¿ 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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15584324
MDR Text Key307078876
Report Number9616656-2022-01104
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number320555
Device Lot Number1342185
Was Device Available for Evaluation? No
Date Manufacturer Received10/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-