MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE

Model Number 371115

Device Problems Hole In Material (1293); Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 03/16/2016

Event Type  malfunction  

Event Description

Customer rejected 1 box due to the packaging having pin holes compromising sterility.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE
• Type of Device: BARD-PARKER CARBON RIB-BACK BLADES SIZE 15
• 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: 5635266
• MDR Text Key: 44999931
• Report Number: 1836161-2016-00032
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 04/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 371115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1