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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 326719
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/18/2018
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone#: (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported with the use of the bd ultra-fine¿ insulin syringe there was an issue with sterile breach. There was no report of injury or further medical intervention.
 
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Brand NameBD ULTRA-FINE¿ INSULIN SYRINGE
Type of DeviceINSULIN SYRINGE WITH NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7745304
MDR Text Key116050332
Report Number1920898-2018-00559
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K955235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326719
Device Lot Number7023616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/02/2018 Patient Sequence Number: 1
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