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 No Known Impact Or Consequence To Patient (2692)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that item number 371115 bard-parker blade was found broken in its packaging.No injury/death reported.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-conformance's 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 could cause blade breakage.The following controls are in-place to mitigate "broken blade" condition at aspen surgical (b)(4) 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 available and no additional information was provided.Based on this information, no further action is required.Device not available.

Event Description

Aspen surgical received a report from the distributor indicating that item number 371115 bard-parker blade was found broken in its packaging.No injury/death reported.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: 8590719
• MDR Text Key: 146246521
• Report Number: 1836161-2019-00038
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371115-150
• Device Lot Number: 0179180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• 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