MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 20, STERILE; BARD-PARKER BLADE

Model Number 371220-150

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 12/29/2017

Event Type  Injury  

Event Description

Item number 371220 bard-parker stainless blade broke during surgery.

Manufacturer Narrative

The incident occurred at the user facility.A sample was returned for evaluation.No manufacturing lot number was provided for review.Customer reported that a bard-parker stainless blade size 20 broke during surgery.The broken blade was retrieved and the patient was noted to be doing well.Follow up care was not required.After evaluation, most probable root cause could have been during the stamping or grinding process.Also, excessive force applied by end user during surgery process could also cause blade breakage.Packing process has established controls to mitigate the condition, including a blade sensor that inspect 100% of packed pouches liner level prior to aluminum foil packaging.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.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a bard-parker blade broke during a procedure.The incident occurred at the user facility.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: BARD-PARKER STAINLESS STEEL BLADES SIZE 20, STERILE
• Type of Device: BARD-PARKER BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 7221180
• MDR Text Key: 98303840
• Report Number: 1836161-2018-00006
• 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,Followup
• Report Date: 12/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 371220-150
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other; Required Intervention