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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD ULTRA FINE-II INSULIN SYRINGE; INSULIN SYRINGE WITH NEEDLE
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BD BD ULTRA FINE-II INSULIN SYRINGE; INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 328418
Device Problems 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 consumer injected with this syringe into the right side of his stomach.After the insulin was injected, and the syringe was pulled out, the needle was missing.The customer feels the needle is inside the skin, however, the doctors feel it fell out.An ultrasound was completed, but the needle was not found.An x-ray was also completed; something was seen, but the needle was never found.No further medical attention is being received.
 
Manufacturer Narrative
A request for rep samples has been made as the actual unit involved is not available for examination.If samples are received, a supplemental report will be submitted upon completion of the investigation.
 
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Brand Name
BD ULTRA FINE-II INSULIN SYRINGE
Type of Device
INSULIN SYRINGE WITH NEEDLE
Manufacturer (Section D)
BD
one becton dr.
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
one becton dr.
franklin lakes, NJ 07417
8015652341
MDR Report Key3800243
MDR Text Key20972212
Report Number2243072-2014-00072
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
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
Date FDA Received05/01/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number328418
Device Lot Number2129345
Is the Reporter a Health Professional? No
Date Manufacturer Received03/31/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2012
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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