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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE

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BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE Back to Search Results
Model Number 328418
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 10/15/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the syringe 1. 0ml 31ga 8mm ufii 10bag 500cs was involved with the patient experiencing an allergic reaction. Lay user/patient reported experiencing an allergic reaction to the device and consulted with their doctor. The doctor said the reaction site was not spreading. No additional information regarding the allergic reaction or its outcome is currently available. The following information was provided by the initial reporter: consumer reported she is allergic to nickel and believes she is having an allergic reaction to the bd needles. Stated she could not locate online what the bd needles are made of. Stated she spoke with her doctor and it does not appear to be spreading. Stated this has been happening over the past couple of days. Informed consumer of the composition of the bd needles and advised of the nickel. Lot # 0041680, cat # 328418. Date of event: unknown.
 
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Brand NameSYRINGE 1.0ML 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 (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10789372
MDR Text Key214753862
Report Number1920898-2020-01536
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number328418
Device Catalogue Number328418
Device Lot Number0041680
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 Received11/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/10/2020
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: 11/04/2020 Patient Sequence Number: 1
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