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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

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE Back to Search Results
Catalog Number 326103
Device Problem Physical Resistance (2578)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that the plunger of a bd ultra-fine¿ insulin syringe was difficult to push. There was no report of exposure, injury or medical intervention.
 
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Brand NameBD ULTRA-FINE¿ INSULIN SYRINGE
Type of DeviceINSULIN SYRINGE
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 Key7635182
MDR Text Key112470881
Report Number1920898-2018-00442
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326103
Device Lot Number6326857
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/21/2016
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: 06/25/2018 Patient Sequence Number: 1
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