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

Model Number	324912
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd veo¿ insulin syringes with bd ultra-fine¿ needle 6mm x 31g there was no expiration date on the product.There was no report of patient impact.The following information was provided by the initial reporter: material no.324912 batch no.6067980.It was reported that expiration date was missing from shelf carton.Date of event: (b)(6) 2022.
Additional Manufacturer Narrative
Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st related complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situation analysis (sa) is required at this time.A complaint history check was performed and this is the 1st related complaint for label information missing (expiration date) on lot # 6067980.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 6067980.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Expiration dates were not printed on packaging until 17nov2017.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no capa/sa is required at this time.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13542538
• Report Number: 1920898-2022-00108
• Device Sequence Number: 4299309
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

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: Other
• Device Expiration Date: 05/04/2021
• Device Model Number: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 6067980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• 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