• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE BARD-PARKER BLADE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371110-150
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2020
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a report indicating that blade broke during a procedure. No injury or death was reported. Item was in use at the end user. No sample or photographic evidence was available for evaluation. A manufacturing lot number was provided for review. Information from the end user noted that blade tip broke off scalpel while in use for skin incision. No surgical intervention was required to retrieve the broken piece and post operative x-ray confirmed that the broken tip was not in the patient. No adverse effect was reported for the patient. Device history record was reviewed and no non-conformance was issued that could be related to reported event. 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 during surgery process 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. Based on this information, no additional actions required. Device not returned.
 
Event Description
Aspen surgical received a report indicating that a blade broke during a procedure. No injury or death was reported. Item was in use at the end user. This report was filed in our complaint handling system as complaint #(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE
Type of DeviceBARD-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 Key10540138
MDR Text Key214813275
Report Number1836161-2020-00041
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 08/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371110-150
Device Lot Number0223350
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/21/2020
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

-
-