MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER CARBON RIB-BCK BLADE SIZE 10; SCALPEL BLADE

Model Number	371110
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the package is not completely sealed.1 each was found during set up for a procedure, no delay occurred.".
Additional Manufacturer Narrative
The actual device was not returned for evaluation; however, we could confirm the complaint based on evaluation of product returned previously of the same lot.The root cause is manufacturing error.If a foil jam occurs on the manufacturing line, it needs to be cleared of affected material so that product can undergo the sealing process.In this case, it appears that was not done, leading to poor seals on some foil pouches.Internally, we are updating our instructions to be clearer about clearing affected material from foil jams.In addition, we are updating the inspection procedure to review seal width more often.These should greatly reduce this type of malfunction moving forward.This should be considered the final report.However, if any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: BARD-PARKER CARBON RIB-BCK BLADE 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: 22122478
• Report Number: 3002750084-2025-00023
• Device Sequence Number: 15191225
• Product Code: GES
• UDI-Device Identifier: 00840113201525
• UDI-Public: 00840113201525
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/02/2025

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: 371110
• Device Lot Number: 409388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Initial Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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