MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER CARBON RIB-BACK BLADES SIZE 15; SCALPEL BLADE

Model Number	37115
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "not sealed on side of packaging.Therefore, not sterile.
Additional Manufacturer Narrative
The device is in process of being returned.Investigation is ongoing.Once we have additional relevant information, it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The actual devices were not returned for evaluation.The root cause is manufacturing error.The most probable root cause for the "foil seal cut off" condition could be a registration malfunction.Nonetheless, foil pouches are inspected 100% by the vision system to sort out nonconforming parts prior to the packaging process, based on dimensional requirements.An improper rejector shooter could contribute to the complaint condition.The registration and vision systems were tested by a mechanic as part of the investigative process, yielding successful results.If any additional relevant information is identified, it will e submitted in a supplemental report.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 15
• Common Device Name: SCALPEL BLADE
• 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: 22161510
• Report Number: 3002750084-2025-00026
• Device Sequence Number: 18018906
• Product Code: GES
• UDI-Device Identifier: 00840113201761
• UDI-Public: 00840113201761
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2025

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: 37115
• Device Lot Number: 410552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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