MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500; Syringe, Piston

Model Number	328440
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
0.3cc 31g syr.10*10 8mm 100's/bx ¿¿:3219230, it has been opened.The customer reported that the product quantity was 88 pieces and the scale was inaccurate.(buy a box of 100 pieces) tmaik 19september2024 additional information attached material: item number: 0.3cc 31g syr.10*10 8mm 100's/bx batch number: 3219230.Reason: consumer printing accuracy questionable (consumers believe that the printing accuracy of 88 out of 100 purchased in a box is questionable) current status: 1) consumers only provide photos, quantities and batch numbers, so they can only upload current information.2) whether the customer has communicated with the consumer or not is a subjective factor of personal judgment.3) the customer contacted the consumer about the batch number, but the consumer did not call back.Second email info attachment: 1) the batch number 3219230 is correctly linked to the catalog number 328440.Because the model number was not filled in on the customer letter (as shown below), the product number was verbally reported incorrectly during the telephone inquiry, and was subsequently reconfirmed to be 328440.

• Brand Name: SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500
• 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: 50945019
• Report Number: 3024508819-2026-00439
• Device Sequence Number: 9552031
• Product Code: FMF
• UDI-Device Identifier: 00382908440035
• UDI-Public: 00382908440035
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: Unknown
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 328440
• Device Lot Number: 3219230
• Was Device Available for Evaluation?: No
• 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: 09/12/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: Asian