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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 328418
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: n/a. 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 by a consumer that the rubber stopper on a bd insulin syringe with the bd ultra-fine¿ needle separated during injection. There was no report of exposure, serious injury or 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 Key7458777
MDR Text Key106655730
Report Number1920898-2018-00258
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
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 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328418
Device Lot Number7191730
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 Received04/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2017
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: 04/25/2018 Patient Sequence Number: 1
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