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

Lot Number 0204656

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

Event Type  malfunction  

Event Description

During procedure, 10 blade broke on the field.All pieces recovered and removed from sterile field.Per hospital policy, radiology notified and x-ray taken.Doctor notified attending surgeon, x-ray negative for foreign body.

• Brand Name: BARD-PARKER
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr. s.e.; caledonia MI 49316
• MDR Report Key: 11594738
• MDR Text Key: 243148171
• Report Number: 11594738
• 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: 03/17/2021

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 Operator: Health Professional
• Device Lot Number: 0204656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA