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

Model Number	324911
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd veo¿ insulin syringes with bd ultra-fine¿ needle it was difficult to aspirate the syringe.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that the syringes will not draw.Lot #: 1347677.Catalog #: 324911.Date of event: unknown.Samples: available - sending mail kit.
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd veo¿ insulin syringes with bd ultra-fine¿ needle it was difficult to aspirate the syringe.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that the syringes will not draw.Lot #: 1347677 catalog #: 324911 date of event: unknown samples: available - sending mail kit.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-aug-2023.H6: investigation summary: customer returned (13) 0.5ml 31ga 6mm syringes loose.It was reported by the consumer that the syringes will not draw.The returned samples visually inspected and observed no damages.Functionality test was performed and observed no issues with withdrawing the liquid into the syringe and flow.No issues of any kind was observed on the return samples.Hence, embecta was not able confirm the reported issues.This batch was created in 2014 and dhr reports are only kept for 7 years.Based on the return samples, embecta was not able to confirm the customer indicated issue.Root cause cannot be determined as the issue is unconfirmed.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• Common Device Name: HYPODERMIC 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: phillip emmert ; 1 becton drive; franklin lakes, NJ 07417 ; 2018474858
• MDR Report Key: 17199045
• Report Number: 1920898-2023-00387
• Device Sequence Number: 5540713
• Product Code: FMF
• UDI-Device Identifier: 00382903249114
• UDI-Public: (01)00382903249114
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023

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: Other
• Device Expiration Date: 02/23/2019
• Device Model Number: 324911
• Device Catalogue Number: 324911
• Device Lot Number: 1347677
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2014
• 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