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

Model Number 371115-150

Device Problems Break (1069); Device Damaged Prior to Use (2284)

Patient Problem No Information (3190)

Event Date 06/29/2017

Event Type  malfunction  

Manufacturer Narrative

The following controls are in-place to mitigate ¿broken blade¿ condition at aspen surgical las piedras site: heat treatment in-process at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.Heat treatment quality inspections at the beginning and end of each lot are inspected for dimension integrity using a pin gauge, flatness gauge and perforation length gauge, ductility test, and hardness test.The 100% visual inspection by certified personnel is performed to segregate nonconforming material, including broken blades, prior to assembly and packaging process.Capa (b)(4) was initiated to evaluate current controls in place corrective actions identified were completed and capa closed on 10/26/2015.Capa (b)(4) was also initiated to continue in the monitoring and improvement of current control.Awareness of the complaint received will be discussed.

Event Description

The blade was broken within the packaging.The sample was not returned for investigation but the customer was able to provide a picture.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE
• Type of Device: BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: megan morrissey ; 6945 southbelt dr. s.e.; caledonia, MI 49316
• MDR Report Key: 6740523
• MDR Text Key: 81129211
• Report Number: 1836161-2017-00074
• 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: 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 371115-150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1