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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 328440
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: 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 that during use a bd insulin syringe with the bd ultra-fine¿ needle malfunctioned as ¿the needle broke off in consumer¿s skin. The needle was bent prior to use. ¿ there was no report of exposure, injury or medical intervention needed.
 
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Brand NameBD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of DeviceINSULIN SYRINGE AND 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 Key7331129
MDR Text Key102212789
Report Number1920898-2018-00147
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 04/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number328440
Device Lot Number7100846
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 Received02/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2017
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: 03/12/2018 Patient Sequence Number: 1
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