MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER DISPOSABLE SCALPELS SIZE 15, STERILE; BARD-PARKER BLADE

Model Number 371615-100

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/23/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the end user indicating that a bard-parker blade broke when the packaging was opened.Sample is available for return.No photographic evidence was available for evaluation.A manufacturing lot number was provided for review.A review of the device history record indicated no non-conformance's related to the reported issue.The most probable root cause could have been 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 end user could also cause blade condition.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.Sample is pending return to manufacturing site and evaluation.No further information is available on the product at this time.However, if any additional relevant information is identified following completion of the evaluation, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a report from the end user indicating that a bard-parker blade broke when the packaging was opened.No injury/death was reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: BARD-PARKER DISPOSABLE SCALPELS 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: 7614180
• MDR Text Key: 111903731
• Report Number: 1836161-2018-00072
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371615-100
• Device Lot Number: 0162270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2017
• 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