MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 22, STERILE; SURGICAL BLADE

Model Number 371122-150

Device Problem Dull, Blunt (2407)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

The following controls are in-place to mitigate ¿broken blade¿ condition at aspen surgical (b)(4): ¿ 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.¿ 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 10/26/15.¿ capa (b)(4) was also initiated to continue in the monitoring and improvement of current control.¿ awareness of the complaint received will be discussed with affected manufacturing personnel on 07/24/17.Device not returned for evaluation.

Event Description

Broken blade- this blade ¿deformation¿ was noticed as they unpackaged it and before it was used on any patients.

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 22, STERILE
• Type of Device: SURGICAL 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: 6751180
• MDR Text Key: 81474725
• Report Number: 1836161-2017-00075
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371122-150
• Device Lot Number: 0133087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2017
• 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