MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. 10FR DRAIN KIT FULL FLUTED WITH TROCAR; WOUND DRAINS

Model Number	332263
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device is available for evaluation.The model number and lot number of the device were also provided.The investigation is ongoing.Once we have completed the investigation, a supplemental report will be submitted with any additional relevant information.
Event or Problem Description
Complainant alleges "one each in the box has an open seal".
Additional Manufacturer Narrative
The actual device was returned for evaluation.During the investigation, no evidence was found to determine how the sample arrived with an open seal.A detailed review of the seals of the returned product confirmed that the seals were intact and functioned as intended.The only plausible way for the seals to be opened is through manual interference.Additionally, a device history record review was conducted, verifying that all inspections were passed.The complaint could not be confirmed, and the root cause was not able to be determined.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: 10FR DRAIN KIT FULL FLUTED WITH TROCAR
• Common Device Name: WOUND DRAINS
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 21423455
• Report Number: 3002750084-2025-00005
• Device Sequence Number: 7591714
• Product Code: GCY
• UDI-Device Identifier: 00840113200047
• UDI-Public: 00840113200047
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: Health Professional
• Device Model Number: 332263
• Device Lot Number: 411823
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown