MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 6MM X 31G; PISTON SYRINGE

Catalog Number	324912
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 6mm x 31g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: parent called on behalf of adult son, stated, when taking injection, he's experienced "leakage" stated"leakage" was coming from needle hub 3 syringes affected.Lot: 1340465.Catalog: 324912.Date of event: unknown.Samples: yes cl.
Additional Manufacturer Narrative
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1340465.All inspection performed per the applicable operations qc specification.
Event or Problem Description
It was reported while using bd veo¿ insulin syringes with bd ultra-fine¿ needle 6mm x 31g leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: parent called on behalf of adult son, stated, when taking injection, he's experienced "leakage" stated"leakage" was coming from needle hub.3 syringes affected.Lot: 1340465 catalog: 324912 date of event: unknown samples: yes cl.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 6MM X 31G
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17763536
• Report Number: 1920898-2023-00630
• Device Sequence Number: 17915935
• 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: Non-Healthcare 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: Other
• Device Catalogue Number: 324912
• Device Lot Number: 1340465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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