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

Model Number 371115

Patient Problem Insufficient Information (4580)

Event Date 09/05/2023

Event Type  malfunction  

Event Description

We were in working on ortho cases and when tech opened the 15 bard-parker® carbon rib-back® blades, the blade itself was wrapped in the paper on the inside that normally splits in half when opened.In order to get the blade out, he had to carefully unwrap it which could have caused an injury.Luckily it didn't but we had that issue will all of our 15 blades that day.Lot: 0339134, expiration: 2028-03-01, ref: 371115, manufacture date: 2023-04-01, 15 bard-parker® carbon rib-back® blades.

• 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: 17984625
• MDR Text Key: 326254007
• Report Number: 17984625
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2023

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: 371115
• Device Lot Number: 0339134
• 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: 09/11/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1