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U.S. Department of Health and Human Services

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

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 15, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371115-150
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 07/20/2018
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that a bard-parker blade was broken. The incident occurred at the user facility. No sample was returned. Photographic evidence and 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. 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. Sample was not returned. However if sample becomes available and any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Aspen surgical received a report from the distributor indicating that a bard-parker blade was broken. The incident occurred at the user facility. This report was filed in our complaint handling system as (b)(4).
 
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Brand NameBARD-PARKER CARBON RIB-BACK BLADES SIZE 15, 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 Key7776899
MDR Text Key117292265
Report Number1836161-2018-00089
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 07/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371115-150
Device Lot Number0141911
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 Received07/20/2018
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

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