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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 329416
Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. Medical device expiration date: n/a. Initial reporter: address unavailable. 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 a bd ultra-fine insulin syringe "was missing the needle. Another syringe had the needle inserted into the plastic end off- center not connected to the chamber. It was also reported that the syringe was loose and when pulled out of the vial the needle had separated from the syringe". No report of serious 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 Key7656404
MDR Text Key113189606
Report Number1920898-2018-00479
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,Followup
Report Date 09/04/2018
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
Device Catalogue Number329416
Device Lot Number7241532
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? Device Not Returned to Manufacturer
Date Device Manufactured10/11/2017
Is the Device Single Use? No
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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