MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE; BARD PARKER BLADE

Model Number 371111

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Eleven (11) blades break in exact same place.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE
• Type of Device: BARD PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer Contact: bradley liske ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 6653455
• MDR Text Key: 78139915
• Report Number: 1836161-2017-00056
• 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: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 371111
• Device Lot Number: 0113584
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1