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

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.

• Brand Name: BD VEO INSULIN SYRINGE WITH BD ULTRA-FINE 6MM NEEDLE
• Type of Device: PISTON 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 Key: 9717709
• MDR Text Key: 189305443
• Report Number: 1920898-2020-00134
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• 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 Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 8043915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other