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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX Back to Search Results
Catalog Number 324892
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Inflammation (1932)
Event Date 08/01/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 5047782. Medical device expiration date: 04/30/2020. Device manufacture date: 02/16/2015. Medical device lot #: 5348743, medical device expiration date: 02/28/2021. Device manufacture date: 12/14/2015. Medical device lot #: 6172646, medical device expiration date: 08/31/2021, device manufacture date: 06/20/2016.
 
Event Description
It has been reported that the syringe 0. 5ml 29ga 12. 7mm blister 200bx has been found experiencing patient-device incompatibility during use. The following has been provided by the initial reporter: inflammatory reaction after administration of a drug with one of the lots mentioned.
 
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Brand NameSYRINGE 0.5ML 29GA 12.7MM BLISTER 200BX
Type of DeviceSYRINGE
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 Key8944364
MDR Text Key155956045
Report Number1920898-2019-00882
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodePO
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number324892
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/29/2019 Patient Sequence Number: 1
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