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

Model Number	324912
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd veo¿ insulin syringes with bd ultra-fine¿ needle experienced foreign matter in fluid path.The following information was provided by the initial reporter: consumer reported that when he drew the insulin from the vial it turned red and became hard inside of the syringe.He stated that he pulled the plunger rod out of the syringe to see if he could get the insulin out but the insulin was hard as a rock inside of the barrel.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes d10: returned to manufacturer on: 19may2023.H6: investigation summary: a complaint lot history check was performed on lot # 2227496 for foreign matter in barrel.This is the 1st related complaint for foreign matter in barrel on lot # 2227496.Investigation summary: customer returned one 1.0ml 31ga 6mm syringe loose with insulin inside the barrel.It was reported that vial turned red and became hard inside of the syringe.Functionality test was performed on the return sample and observed no issues with flow.Hence, the alleged issue could not be confirmed.A review of the device history record was completed for batch# 2227496.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted for failed sustaining.Unconfirmed: based on the sample received, embecta was not able to confirm the customer indicated failure.Root cause is not determined as the issue is unconfirmed.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.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd veo¿ insulin syringes with bd ultra-fine¿ needle experienced foreign matter in fluid path.The following information was provided by the initial reporter: consumer reported that when he drew the insulin from the vial it turned red and became hard inside of the syringe.He stated that he pulled the plunger rod out of the syringe to see if he could get the insulin out but the insulin was hard as a rock inside of the barrel.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• Common Device Name: 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16826179
• Report Number: 1920898-2023-00262
• Device Sequence Number: 6987448
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: (01)00382903249121
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 2227496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown