MAUDE Adverse Event Report:; SHARPS CONTAINER

Model Number	MS-64250, 64250
Medical Device Problem Codes	Nonstandard Device (1420); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Sharps dart locking mechanism does not remain permanently locked.Part and lot numbers involved: ms-64250 - 1011735 and 1012015.64250 - 1011532, 1011528, 1011581, 1011585, 1011955, 1011967, 1012051, and 1012206.

• Common Device Name: SHARPS CONTAINER
• MDR Report Key: 24059764
• Report Number: 3003674698-2026-00182
• Device Sequence Number: 18478748
• Product Code: MMK
• UDI-Device Identifier: 00816703021392
• UDI-Public: 00816703021392
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K180984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace,Notification,Recall
• Type of Report: Initial

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
• Device Model Number: MS-64250, 64250
• Device Catalogue Number: MS-64250, BT-64250
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown