MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PET SYRINGES VETERINARY INSULIN SYRINGE; PISTON SYRINGE

Model Number	323000
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd pet syringes veterinary insulin syringe was damaged.The following information was provided by the initial reporter: wanted to report this bent syringe from a lot of u-40, syringes i purchased for my dog.
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.
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.Investigation summary: the customer returned (1) 0.3ml 29ga vet syringe reporting damaged barrel.The syringe was visually inspected.Upon visual inspection, embecta was able to confirm the reported failure of damaged barrel.A review of the device history record was completed for batch# 2136583.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to duplicate or confirm the customer¿s indicated failure of damaged / deformed barrel.A definitive root cause cannot be determined.H3 other text : see h10.
Event or Problem Description
It was reported that the bd pet syringes veterinary insulin syringe was damaged.The following information was provided by the initial reporter: wanted to report this bent syringe from a lot of u-40, syringes i purchased for my dog.

• Brand Name: BD PET SYRINGES VETERINARY INSULIN SYRINGE
• 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: 16358213
• Report Number: 1920898-2023-00045
• Device Sequence Number: 12341963
• Product Code: FMF
• UDI-Device Identifier: 00382903230006
• UDI-Public: (01)00382903230006
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/23/2023

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: 01/17/2023
• Supplement Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/27/2023
• 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