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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON BD MICRO-FINE PLUS INSULIN PEN NEEDLE
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BECTON DICKINSON BD MICRO-FINE PLUS INSULIN PEN NEEDLE Back to Search Results
Catalog Number 320136
Device Problems Bent (1059); Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/01/2015
Event Type  Injury  
Event Description
It was reported that using a bd micro-fine plus insulin pen needle, the needle broke of fin use in the patient's injection site.The patient received an x-ray and the needle was removed via surgery.Of note, the patient's family reported that the needle was bent and that they straightened it prior to its use and subsequent breakage.
 
Manufacturer Narrative
Results.A sample is not available for evaluation.A review of the device history records could not be completed as a lot # for this incident was not provided.Without a sample, an absolute root cause for this incident cannot be determined.(b)(4).
 
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Brand Name
BD MICRO-FINE PLUS INSULIN PEN NEEDLE
Type of Device
INSULIN PEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton dr.
franklin lakes NJ 07417
Manufacturer Contact
aaron larson
1 becton dr.
franklin lakes, NJ 07417
8015652406
MDR Report Key4730733
MDR Text Key5585577
Report Number2243072-2015-00066
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/21/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number320136
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/02/2015
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
Patient Outcome(s) Required Intervention;
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