MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ 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	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd veo¿ insulin syringe with the bd ultra-fine¿ needle was unable to inject insulin.The following information was provided by the initial reporter: "1st plunger issue -chunk out of the plastic missing, was not able to push insulin in.2nd the needle has a burr, extra chunk on needle and cant come off.Some metal deformation.Injury- no.".
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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: 08-may-2023 h6: investigation summary the customer returned (1) 1.0ml g 31 ga 6mm syringe, reporting difficult to operate (not drawing).The syringe was visually examined under microscope and observed no damages to the cannula.A functionality test was performed on the returned sample and no issues related to drawing was observed.Based on the sample received and visual examination, embecta was not able to confirm the reported failure.A review of the device history record was completed for batch# 2227496.All inspections and challenges were performed per the applicable operations qc specifications.Based on the sample received, embecta was not able to duplicate or confirm the customer-indicated failure.The root cause cannot be determined, as the reported failure could not be confirmed.H3 other text : see h10.
Event or Problem Description
It was reported that the bd veo¿ insulin syringe with the bd ultra-fine¿ needle was unable to inject insulin.The following information was provided by the initial reporter: "1st plunger issue -chunk out of the plastic missing, was not able to push insulin in.2nd the needle has a burr, extra chunk on needle and cant come off.Some metal deformation.Injury- no".

• Brand Name: BD VEO¿ INSULIN SYRINGE WITH THE 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: 16771574
• Report Number: 1920898-2023-00238
• Device Sequence Number: 19646302
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/27/2023

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: 03/29/2023
• Supplement Date Received by Manufacturer: 07/27/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 08/14/2023
• 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