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

Model Number	373915
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The complaint was able to be confirmed based on pictures provided.However, without the actual device to evaluate it is very difficult to determine a root cause of the malfunction.The root cause is undetermined.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 "we have seen two #15 safety blades with the safety coming off when attempting to remove the blade.Both were from vascular packs.Same lot # for both.Unsure if this is just an issue with this particular lot #.".

• Brand Name: BARD-PARKER SAFETY BLADES SIZE 15, STERILE
• 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: 24702242
• Report Number: 3002750084-2026-00035
• Device Sequence Number: 10110063
• Product Code: GES
• UDI-Device Identifier: 00840113203116
• UDI-Public: 00840113203116
• 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): 03/26/2026

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: 373915
• Device Lot Number: 0465256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/26/2026
• 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