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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD MICRO-FINE PLUS 31GA PEN NEEDLE; PEN NEEDLE, 31GA
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BD BD MICRO-FINE PLUS 31GA PEN NEEDLE; PEN NEEDLE, 31GA Back to Search Results
Catalog Number 320212
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Type  Injury  
Event Description
The user was injecting insulin with the pen needle/ when doing this, the needle broke and went into the patient's tissue.This was discovered when the user pulled out the needle and only the attachment was left on the pen.The user had an x-ray, but the needle could not be found.The user is an experienced diabetic who inject insulin several times per day.The need had never been used before the incident occurred.
 
Manufacturer Narrative
Samples are available for evaluation.Upon receipt of the samples and completion of the investigation, a supplemental report will be submitted.(b)(4).
 
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Brand Name
BD MICRO-FINE PLUS 31GA PEN NEEDLE
Type of Device
PEN NEEDLE, 31GA
Manufacturer (Section D)
BD
1 becton dr.
franklin lakes NJ 07417 188
Manufacturer Contact
amy bodell
1 becton dr.
franklin lakes, NJ 07417-1880
8015652585
MDR Report Key3815594
MDR Text Key4405807
Report Number2243072-2014-00074
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeSW
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 05/06/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2018
Device Catalogue Number320212
Device Lot Number3135368
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/09/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2013
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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