MAUDE Adverse Event Report: EMBECTA MEDICAL II LLC - PARSIPPANY, NJ SHARPS CONTAINER 1.4 QT HOME; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	323487
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported that her home sharps container had a large hole at the bottom.It appeared that the container was melted where the hole was formed.Lot #: 3157001 catalog #: 323487 date of event: 04-05-24 samples: available - sending mail kit.
Additional Manufacturer Narrative
Additional information was added to: b4, g6, h11 investigation summary: the investigation is currently in progress.Once the investigation is completed, a detailed summary will be provided.
Additional Manufacturer Narrative
Additional information provided to sections b4, g6, h2, h3, and h11.Corrections made to section h6 (component code, type of investigation, investigation findings, & investigation conclusions).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 and based on trend analysis no further action is required at this time.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: SHARPS CONTAINER 1.4 QT HOME
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): EMBECTA MEDICAL II LLC - PARSIPPANY, NJ
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 19201872
• Report Number: 3022699058-2024-00002
• Device Sequence Number: 8048812
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K943139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/04/2026

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: 323487
• Device Lot Number: 3157001
• 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: 04/05/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 07/26/2024; 08/13/2024; 09/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown