MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO INSULIN SYRINGE W/ ULTRA FINE NEEDLE

Catalog Number 320930

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

It was reported that the bd veo insulin syringe w/ ultra fine needle experienced difficult plunger movement.The following information was provided by the initial reporter: a very tight syringe plunger.The client cannot control the plunger during the administration of small doses of the drug (botulinum toxin; sodium chloride solution for injection in forehead, glabellar area, nasal bridge, the skin around the eyes).

Manufacturer Narrative

Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was not able to duplicate or confirm the indicated issue.Hence a potential root cause cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.A complaint lot history check was performed on lot # 0027302 for plunger rod difficult/unable to operate.This is the 1st related complaint for plunger rod difficult/unable to operate on lot # 0027302.It was noted that the plungers could be operated without issue.No damage to the needles of any kind was observed and the needles functioned as intended.A review of the device history record was completed for batch# 0027302.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200875141] noted that did not pertain to the complaint.There was one (1) notification [200875006] noted for excessive adhesive.Based on the samples received, bd was unable to replicate or confirm the customer¿s indicated failure of the plunger rods being difficult to move.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.The root cause cannot be determined at this time as the issue is unconfirmed.Based on the investigation, no capa/sa is required at this time.

• Brand Name: BD VEO INSULIN SYRINGE W/ ULTRA FINE NEEDLE
• Type of Device: INSULIN 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13005599
• MDR Text Key: 282292282
• Report Number: 1920898-2021-01303
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KZ
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320930
• Device Lot Number: 0027302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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