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

Model Number 373910

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/03/2017

Event Type  Injury  

Event Description

The bard -parker blade safety blade size 10 was attached to a reusable bard-parker blade holder for a surgical case.The metal blade fell off the grey plastic sheath during use.No injury.

• Brand Name: BARD-PARKER SAFETY BLADE
• Type of Device: SAFETY BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC. ; caledonia MI 49316
• MDR Report Key: 6497068
• MDR Text Key: 73066814
• Report Number: MW5069103
• Device Sequence Number: 1
• Product Code: GES
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 373910
• Device Lot Number: 0118573
• Is the Reporter a Health Professional?: No
• 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
• Patient Outcome(s): Required Intervention