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

Model Number	324912
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: na.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 while using bd veo¿ insulin syringes with bd ultra-fine¿ 6mm x 31g needle insulin was unable to be drawn.The following information was provided by the initial reporter: it was reported that she was unable to draw up insulin.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 9/13/2021.H.6.Investigation: customer returned a single syringe inside a polybag labeled for 1.0ml, 31 gauge, 6mm syringes from lot 6032894.The syringe was placed in water and the plunger rod was retracted in order to draw the water into the syringe.Water was drawn up into the syringe and filled it within a short period of time.The syringe was undamaged and functioned as intended.A review of the device history record was completed for batch# 6032894.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the sample received, bd was unable to replicate or confirm the customer¿s indicated failure of the syringe not drawing insulin.
Event or Problem Description
It was reported that while using bd veo¿ insulin syringes with bd ultra-fine¿ 6mm x 31g needle insulin was unable to be drawn.The following information was provided by the initial reporter: it was reported that she was unable to draw up insulin.

• Brand Name: BD VEO INSULIN SYRINGES WITH BD ULTRA-FINE 6MM X 31G NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12425860
• Report Number: 1920898-2021-00962
• Device Sequence Number: 3245139
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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 Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 6032894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1