MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ PET SYRINGES VETERINARY INSULIN SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	323000
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.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 the bd¿ pet syringes veterinary insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: consumer reported found 1 syringe without any scale marking on the barrel of syringe.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: (b)(6) 2023.H6: investigation summary the customer returned (1) 0.3ml 29g 12.7mm syringe, reporting scale marking missing.The syringe was visually examined and observed no scale markings on the barrel.Based on the sample received and visual examination, embecta was able to confirm the reported failure.A review of the device history record was completed for batch # 2136583 all inspections were performed per the applicable operations qc specifications.Based on the sample received, embecta was able to confirm the customer-indicated failure.No root cause can be determined.
Event or Problem Description
It was reported that the bd¿ pet syringes veterinary insulin syringe experienced scale marking issues.The following information was provided by the initial reporter: consumer reported found 1 syringe without any scale marking on the barrel of syringe.

• Brand Name: BD¿ PET SYRINGES VETERINARY INSULIN SYRINGE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 16812463
• Report Number: 1920898-2023-00257
• Device Sequence Number: 14898162
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: (01)00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 07/20/2023

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: 323000
• Device Catalogue Number: 323000
• Device Lot Number: 2136583
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 04/25/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2022
• 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