MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE; HYPDERMIC SINGLE LUMEN NEEDLE

Model Number	324909
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with an unspecified amount of bd veo¿ insulin syringes with bd ultra-fine¿ needle the hub is damaged and "appears to be burnt/melted".2 of 2 issues.The following information was provided by the initial reporter: consumer also stated that the needle hub is damaged, appeared to be burnt/melted.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 28-aug-2023 h6: investigation summary customer returned (1) 0.3ml 31ga 6mm syringe in an open polybag from the lot# 2213816.It was reported by the consumer that needle is bent and do not allow any liquid to go through.Consumer also stated that the needle hub is damaged.The returned samples visually verified and observed no damages.Functionality test was performed and observed no issues.No issues of any kind was observed on the returned samples.Therefore, embecta was not able to confirm the customer reported issues.A review of the device history record was completed for batch # 2213816 all inspections were performed per the applicable operations qc specifications.H3 other text : see h10.
Event or Problem Description
It was reported that during use with an unspecified amount of bd veo¿ insulin syringes with bd ultra-fine¿ needle the hub is damaged and "appears to be burnt/melted".2 of 2 issues.The following information was provided by the initial reporter: consumer also stated that the needle hub is damaged, appeared to be burnt/melted.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• Common Device Name: HYPDERMIC SINGLE LUMEN NEEDLE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17344987
• Report Number: 1920898-2023-00449
• Device Sequence Number: 12486060
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: (01)00382903249091
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• 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): 10/12/2023

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: 324909
• Device Catalogue Number: 324909
• Device Lot Number: 2213816
• 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: 06/27/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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