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

Model Number 371110

Patient Problem Insufficient Information (4580)

Event Date 07/07/2023

Event Type  malfunction  

Event Description

When package was opened, blade is sealed inside inner protective pouch.Tech is unable to get it out of protective pouch.They have had 3 of these issues in the past week.Only 1 is currently available for return.

• 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: 17469081
• MDR Text Key: 320503041
• Report Number: 17469081
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/07/2023

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 Catalogue Number: 371110
• Device Lot Number: 0326499
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1