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

Model Number 371115-150

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

Aspen surgical received a letter from the fda (uf/importer report # (b)(4)) indicating that item number 371115 bard-parker blade broke in a patient during a procedure. The incident occurred at the user facility. A manufacturing lot number was provided for review. A review of the device history record was completed and no non-conformances related to the reported issue were identified. The most probable root cause could have been machine related during the stamping or grinding process. Packaging process has established controls to mitigate broken or cracked blade condition, including a "medio" blade sensor that inspects 100% of packed pouches liner level prior to aluminum foil packaging. Also, excessive force applied by the end user during surgery process could cause blade breakage. 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. No sample was returned and no additional information was provided from the end user. Based on this information, no further action is required.

Event Description

Aspen surgical received a letter from the fda (uf/importer report # (b)(4)) indicating that item number 371115 bard-parker blade broke in the patient during a procedure. Incident occurred at the end user. This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, 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: 8536456
• MDR Text Key: 142672295
• Report Number: 1836161-2019-00037
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 371115-150
• Device Lot Number: 0164104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 04/22/2019 Patient Sequence Number: 1