MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 6MM; PISTON SYRINGE

Model Number	324911
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd veo¿ insulin syringes with bd ultra-fine¿ needle 1/2ml 6mm there was a sharp protrusion on the plunger.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that there is a sharp edge under the thumb press on the plunger rod.He stated that he gets cut when he pulls the plunger rod out, stated that the cut is similar to a paper cut.
Additional Manufacturer Narrative
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 1/2ml 6mm there was a sharp protrusion on the plunger.There was no report of patient impact.The following information was provided by the initial reporter: consumer reported that there is a sharp edge under the thumb press on the plunger rod.He stated that he gets cut when he pulls the plunger rod out, stated that the cut is similar to a paper cut.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-feb-2023.H6: investigation summary customer returned (7) syringe 0.5ml 31ga 6mm loose.It was reported by the consumer that there is a sharp edge under the thumb press which causes customer to get a paper-cut-like cut.All the syringes were examined using magnification and found no evidence of sharp edges to the plunger thumb press that could lead to cut.Hence, the alleged issue could not be confirmed based on the samples return for the investigation.A review of the device history record was completed for batch# 0090596.All inspections and challenges were performed per the applicable operations qc specifications.Based on the sample received, embecta was not able to confirm the customer indicated failure.Root cause is not determined as the issue is unconfirmed.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1/2ML 6MM
• 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: 16358497
• Report Number: 1920898-2023-00046
• Device Sequence Number: 6270332
• Product Code: FMF
• UDI-Device Identifier: 00382903249114
• UDI-Public: (01)00382903249114
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/04/2023

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: 04/30/2025
• Device Model Number: 324911
• Device Catalogue Number: 324911
• Device Lot Number: 0090596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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