MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 1.0ML 31GA 6MM 10BAG 500CS; SYRINGE, PISTON

Model Number	324912
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported, when she started to take her injection, the insulin leaked out and that's when she noticed, the barrel was cracked.(b)(4) syringe affected.Lot: 3065974.Catalog: 324912.Date of event: 2024-03-14.Samples: yes (b)(6).
Additional Manufacturer Narrative
Additional information provided to sections b4, g6, h2, h3, and h11.Corrections made to section h6 (medical device problem code).Investigation summary not yet available.Once the investigation is completed, the investigation summary will be provided.
Additional Manufacturer Narrative
Investigation summary: samples were received and an investigation was performed.Embecta was able to duplicate or confirm the indicated issue.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.

• Brand Name: SYRINGE 1.0ML 31GA 6MM 10BAG 500CS
• 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: 19067819
• Report Number: 1920898-2024-05076
• Device Sequence Number: 20507161
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• 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,Followup
• Report Date (Section B): 07/26/2024

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: 324912
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/03/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown