MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE

Model Number	324906
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 5 bd veo¿ insulin syringes with bd ultra-fine¿ needles experienced product damage while still considered operable.The following information was provided by the initial reporter: consumer reported found the top of syringe to 5 units were melted.Caller drew into syringe humalog and then noticed the outside of barrel to be melted.Caller did not inject with this syringe.
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.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 5 bd veo¿ insulin syringes with bd ultra-fine¿ needles experienced product damage while still considered operable.The following information was provided by the initial reporter: consumer reported found the top of syringe to 5 units were melted.Caller drew into syringe humalog and then noticed the outside of barrel to be melted.Caller did not inject with this syringe.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?yes,.D10: returned to manufacturer on: 03-jan-2023 h6: investigation summary customer returned two syringes 0.3ml 6mm 90 bx 450 mo.Customer reported that they found the top of syringe to the 5 unit to be melted.Caller drew into syringe humalog and then noticed the outside of barrel to be melted.Caller did not inject with this syringe.However, the syringes were visually inspected.One of the returned syringes was found damaged/scratched on the top the barrel at 5 unit marking.No damages were found on the second returned syringe.A review of the device history record was completed for batch# 1263405.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples received, embecta was able to confirm the customer¿s indicated failure on one of the returned syringes.Root cause: from the print carousel, the barrels transition to the transfer dial and onto individual guides that carry the barrels through an oven to cure the ink to the barrel.The printed barrels were getting damaged at the transfer dial to the oven guides.H3 other text : see h10.

• Brand Name: BD VEO¿ INSULIN SYRINGE WITH 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15936667
• Report Number: 1920898-2022-00859
• Device Sequence Number: 15007633
• Product Code: FMF
• UDI-Device Identifier: 50382903249065
• UDI-Public: 00382903249060
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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: 324906
• Device Catalogue Number: 324906
• Device Lot Number: 1263405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 02/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2021
• 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