MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER SAFETY BLADES SIZE 11 STERILE; SAFETY SCALPEL BLADE

Model Number	373911
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	Laceration(s) (1946)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation, and no pictures of the device were provided so the complaint could not be confirmed.It is difficult to determine a root cause with no sample to evaluate, however we suspect there may have been a manufacturing error that led to this incident.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "yesterday we had a student cut herself when attempting to slide the protective cover over the blade.She was taking the blade off of the handle at the end of the case.She had a puncture wound to her hand, but the injury was not serious and did not require any dressings or sutures.".

• Brand Name: BARD-PARKER SAFETY BLADES SIZE 11 STERILE
• Common Device Name: SAFETY 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: 23357780
• Report Number: 3002750084-2025-00054
• Device Sequence Number: 18414746
• Product Code: GES
• UDI-Device Identifier: 00840113203086
• UDI-Public: 00840113203086
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/22/2025

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: 373911
• Device Lot Number: 0351360
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 10/22/2025
• 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