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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE Back to Search Results
Catalog Number 328468
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/09/2019
Event Type  Injury  
Manufacturer Narrative
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 an unspecified number of syringe 0. 5ml 31ga 8mm ufii 10bag 500cs experienced the cannula breaking off or pulling out during use, and serious injury in the form of medical intervention. The consumer stated that the cannula broke off beneath the skin and they were unable to pull it out. The consumer sought urgent care, but there is no additional information regarding the outcome of the medical intervention. The following information was provided by the initial reporter: material no: 328468 ; batch no: 8232928. Verbatim: issue(s): needle break off in site (ab) during injection. Does not reuse needles. Unable to pull out on her own. Consumer stated going to the urgent care now. Can see the needle under her skin. Lot #: 8232928. Item #: 328468. Date of event: (b)(6) 2019.
 
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Brand NameSYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
Type of DevicePISTON 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
8015652341
MDR Report Key9527197
MDR Text Key183906461
Report Number1920898-2019-01478
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number328468
Device Lot Number8232928
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/20/2018
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: 12/27/2019 Patient Sequence Number: 1
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