MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER ® CARBON RIB-BACK BLADES; BLADE, SCALPEL

Model Number 371110

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2023

Event Type  malfunction  

Event Description

Rusted after opening blade packet on sterile field.

• Brand Name: BARD-PARKER ® CARBON RIB-BACK BLADES
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt drive s.e; caledonia MI 49316
• MDR Report Key: 18920725
• MDR Text Key: 337859457
• Report Number: 18920725
• Device Sequence Number: 1
• Product Code: GES
• UDI-Device Identifier: 00840113201532
• UDI-Public: (01)00840113201532(11)230301(17)280229(10)0334610(30)50
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2024

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
• Device Model Number: 371110
• Device Lot Number: 0334610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1