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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE PISTON SYRINGE Back to Search Results
Model Number 324912
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hyperglycemia (1905)
Event Date 02/07/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: a complaint history check was performed and this is the 1st related complaint for glucose level on lot # 8043915. No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined. Complaints received for this device and reported condition will continue to be tracked and trended. If samples are received in the future the complaint will be reopened for further investigation. A review of the device history record was completed for batch# 8043915. All inspections were performed per the applicable operations qc specifications. There was one (1) notification [200745125] notification noted that did not pertain to the complaint. There was one (1) notification [200743168] noted for ink splatters. Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that hyperglycemia occurred during use with a bd veo¿ insulin syringe with bd ultra-fine 6mm needle. The following information was provided by the initial reporter: consumer reported that she is unable to keep her glucose level down.
 
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Brand NameBD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE
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 Key9717709
MDR Text Key189305443
Report Number1920898-2020-00134
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
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number324912
Device Catalogue Number324912
Device Lot Number8043915
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 Received02/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2018
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: 02/17/2020 Patient Sequence Number: 1
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