MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG; SYRINGE, PISTON

Model Number	324909
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported, she found one syringe in her pack with "scale markings in red ink" and syringe said, "u-40" and markings were counting by "two's".Stated, the remaining syringes she has in package and box, the scale markings are "black ink" and is u-100.Stated, she did not use the syringe that was in red.Wanted to find out first if it was okay to use.1 syringe affected lot: 2213816 catalog: 324909 date of event: 2024-03-16 sample: yes cl.
Additional Manufacturer Narrative
Correction to (type of investigation).Investigation summary not available yet.Once the investigation is completed.Investigation summary will be provided.
Additional Manufacturer Narrative
Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue.A process non-conformance 200000067 has been opened for the line clearance and change over documentation to investigate improvements of the process.An initiative to reduce the frequency of product mix incidents by mitigating faults caused by line clearances has been started as part of the manufacturing plants focused improvement efforts.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured and monitored on trend reports.Our business team regularly reviews the collected data to identify emerging trends.Based on the above, no corrective/preventative action (capa) or situational analysis (sa) is required.

• Brand Name: SYRINGE 0.3ML 31GA 6MM WHOLEUNIT 10BAG
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 19083523
• Report Number: 1920898-2024-05079
• Device Sequence Number: 8359186
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: 00382903249091
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212499
• 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,Followup
• Report Date (Section B): 07/25/2024

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: 324909
• Device Lot Number: 2213816
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: Not provided; 07/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 07/03/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown