MAUDE Adverse Event Report: ASPEN SURGICAL, INC. BARD-PARKER STAINLESS STEEL BLADE #10; BLADE, SCALPEL

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Information (3190)

Event Date 03/25/2019

Event Type  malfunction  

Event Description

The 10 blade in it's bard-parker original packaging is contained in one of our surgical packs.When the scrub nurse began peeling open the outer metal packaging, the inner paper packaging over blade did not peel back on either side to expose the blade.Blade with packaging passed off sterile field and additional bard parker 10 blade obtained from supply cart and opened on sterile field.Staff reported the same event on prior procedure but the scrub used heavy scissors to cut blade out of packaging.

• Brand Name: BARD-PARKER STAINLESS STEEL BLADE #10
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL, INC.; 6945 southbelt drive se; caledonia MI 49316
• MDR Report Key: 8514336
• MDR Text Key: 141953595
• Report Number: 8514336
• 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: 03/26/2019

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: Other
• 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: 03/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1