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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 928857
Device Problems Retraction Problem (1536); Component Missing (2306); Difficult to Advance (2920); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. 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 insulin syringe with bd ultra-fine¿ needle there was an issue with multiple issues. It was stated by the user ¿the needle was bent before use, the needle was missing, the plunger rod was difficult to move, the plunger rod was missing and the barrel was bent¿. There was no report of injury or further medical intervention.
 
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Brand NameBD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
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 Key7655862
MDR Text Key113190607
Report Number1920898-2018-00485
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient
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 Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number928857
Device Lot Number7177911
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 Received06/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2017
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: 07/02/2018 Patient Sequence Number: 1
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