MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS; SYRINGE, PISTON

Model Number	328468
Medical Device Problem Codes	Off-Label Use (1494); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Pet owner reported -i get your bd syringes (1/2 ml) monthly for my 2 cats.Have been for the past year now, but the last few months i have syringes that just don't work.There is no suction when trying to get the insulin out of pen.Is there an issue with these.They are not cheap and i am getting rid of at least 2 in each bag.Please any info would be great.If they have to write for different needles i need to let them know.Item # 328468.
Additional Manufacturer Narrative
Additional information provided to sections.Corrections made to sections e1 (reporter name and address), g2 (report source), g3 (date received by manufacturer), and h6 (type of investigation & investigation conclusions).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.Based on the above, no additional investigation and no capa/sa is required at this time.

• Brand Name: SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): EMBECTA MEDICAL I LLC - HOLDREGE, NE
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 19127575
• Report Number: 3024508819-2024-00002
• Device Sequence Number: 20743410
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: (01)00382908468039
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 328468
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 03/25/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown