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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 AND NEEDLE HYPODERMIC SYRINGE AND NEEDLE

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BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE AND NEEDLE HYPODERMIC SYRINGE AND NEEDLE Back to Search Results
Catalog Number 328325
Device Problems Bent (1059); Material Perforation (2205); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem Needle Stick/Puncture (2462)
Event Date 11/21/2017
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. (b)(6). 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 before use, a bd ultra-fine insulin syringe and needle was found with the needle bent and through the orange protection cap. The package was perforated injuring an employee. There was no report found of medical intervention needed or performed regarding the "employee injury. ".
 
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Brand NameBD ULTRA-FINE INSULIN SYRINGE AND NEEDLE
Type of DeviceHYPODERMIC 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 Key7113215
MDR Text Key95072603
Report Number1920898-2017-00369
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number328325
Device Lot Number7044954
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/13/2017
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: 12/13/2017 Patient Sequence Number: 1
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