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

Model Number	324911
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to use with bd veo¿ insulin syringes with bd ultra-fine¿ needle the scale markings were missing.The following information was provided by the initial reporter: "1 defective syringe in package of 10 syringe missing volume labels, needed to use 3 units but there was none so she couldn't use it".
Additional Manufacturer Narrative
Date of event: unknown.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 prior to use with bd veo¿ insulin syringes with bd ultra-fine¿ needle the scale markings were missing.The following information was provided by the initial reporter: "1 defective syringe in package of 10 syringe missing volume labels, needed to use 3 units but there was none so she couldnt use it".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-jun-2023.H6: investigation summary: customer returned (1) 0.5ml 31ga 6mm syringe in an open polybag from the lot# 2199434.It was reported by the consumer that 1 defective syringe in package of 10 syringe missing volume labels, needed to use 3 units but there was none so she couldn't use it.The returned syringe was examined and observed missing (light printing) scale marking lines around 5 unit.A review of the device history record was completed for batch# 2199434.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to confirm the customer¿s indicated failure.Root cause analysis: there was one notification (zm 201034109) noted which is for missing print that had occurred due to ink flow restride causing blank spots on drum causing dry ink on drum that pertained to the missing print complaint.H3 other text : see h10.

• Brand Name: BD VEO¿ INSULIN SYRINGES 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 ; 8448235433
• MDR Report Key: 17140098
• Report Number: 1920898-2023-00362
• Device Sequence Number: 14945481
• Product Code: FMF
• UDI-Device Identifier: 00382903249114
• UDI-Public: (01)00382903249114
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/31/2023

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: 324911
• Device Catalogue Number: 324911
• Device Lot Number: 2199434
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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