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

Model Number	371215
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleges "the packaging is no longer sealed.It has separated exposing the blade.It seems to be all the blades from this lot.".
Additional Manufacturer Narrative
The device is in process of being returned for evaluation, and the investigation is ongoing.Once we have additional relevant information it will be submitted in a supplemental report.
Additional Manufacturer Narrative
The devices were returned for evaluation.Based on supplier evluation, the delamination was caused by a stop/start process interruption in which the adhesive nip roller was disengaged.At that time, the product should have been properly flagged to identify the stop/start condition, but the supplier failed to identify and remove the defective, flagged product from the roll.The root cause was a manufacturing error, specifically due to material handling at the supplier.As a corrective action, the supplier updated their standard work instruction for flagging and removing material defects to include clearer guidance and expectations for operators when reconciling flagged material.If any additional relevant information is identified it will be submitted in a supplemental report.

• Brand Name: BARD-PARKER STAINLESS STEEL 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: 24631002
• Report Number: 3002750084-2026-00027
• Device Sequence Number: 12994849
• Product Code: GES
• UDI-Device Identifier: 00840113204380
• UDI-Public: 00840113204380
• 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,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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: 371215
• Device Lot Number: 0477931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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