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 BD MICRO-FINE ULTRA 31G PEN NEEDLE; PEN NEEDLE, 31GA
  • 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 BD MICRO-FINE ULTRA 31G PEN NEEDLE; PEN NEEDLE, 31GA Back to Search Results
Catalog Number 325108
Device Problems Break (1069); Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
The customer reported the needle bending during use on a regular basis.The needle broke in the user's thigh, and an x-ray was performed.It was difficult to locate the broken part of the needle and the surgeon did not want to operate on the patient.The needles were used with victoza pre-filled pens.
 
Manufacturer Narrative
The sample is not available for evaluation.Without a sample, a root cause for this incident could not be identified.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD MICRO-FINE ULTRA 31G PEN NEEDLE
Type of Device
PEN NEEDLE, 31GA
Manufacturer (Section D)
BECTON DICKINSON
1 becton dr.
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
1 becton dr.
franklin lakes, NJ 07417
8015652341
MDR Report Key3802855
MDR Text Key4365066
Report Number2243072-2014-00086
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number325108
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/18/2014
Initial Date FDA Received05/01/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-