MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER SS BLADES SIZE 10; SCALPEL BLADE

Model Number	371210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.The most likely root cause is manufacturing error, which may be in forming the device or it may also be due to operator error in not catching the device during 100% visual inspection.The root cause may also be attributed to user errer, as excessive force may cause blade breakage.This should be considered the final report.If any additional relvevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "bard-parker blade broke while in use.Both pieces were retrieved and verified by (b)(6), rn and md that all pieces were accounted for.".

• Brand Name: BARD-PARKER SS BLADES SIZE 10
• 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: 22789230
• Report Number: 3002750084-2025-00038
• Device Sequence Number: 8236811
• Product Code: GES
• UDI-Device Identifier: 00840113204182
• UDI-Public: 00840113204182
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: 371210
• Device Lot Number: 414397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 08/12/2025
• 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