MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER RIB-BACK CARBON STEEL SURGICAL BLADE (NO. 10); BLADE, SURGICAL

Catalog Number 0086

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/21/2020

Event Type  malfunction  

Event Description

Dull bard-parker blade (no.10) in package.Would not cut through muscle.Fda safety report id# (b)(4).

• Brand Name: BARD-PARKER RIB-BACK CARBON STEEL SURGICAL BLADE (NO. 10)
• Type of Device: BLADE, SURGICAL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC. ; caledonia MI 49316
• MDR Report Key: 9763993
• MDR Text Key: 181771070
• Report Number: MW5093344
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2020

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 Catalogue Number: 0086
• Device Lot Number: 0200328
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1