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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 Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2017
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received medwatch report # (b)(4) which was requested by aspen surgical during a monthly review of the fda's maude database. As indicated in the report, a surgical tech was loading the bard-parker blade into a knife handle before the procedure was to start and the blade broke into three pieces. User facility did not report the incident to aspen surgical. No customer information was available in the maude report. Part number and manufacturing lot number was available. Event occurred in a hospital. No injury or death was reported. Based on the evaluation conducted, lot 0118976 was packed per dhr and no non-conformance related to the broken blade were present. Packing process has established controls to mitigate broken blade condition, including a blade sensor that inspect 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 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 further action is required. Device not available.
 
Event Description
Aspen surgical received information from a maude event report (foi) which was requested by aspen surgical. The report was identified during a monthly review of the fda's maude database. The report indicated that a bard-parker blade broke upon loading into the knife handle. The incident occurred at the user facility. This report was filed in our complaint handling system as complaint # (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 Key7305837
MDR Text Key101629852
Report Number1836161-2018-00025
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 health professional,user faci
Reporter Occupation
Type of Report Initial
Report Date 01/31/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other Health Care Professional
Device Model Number371115-150
Device Lot Number0118976
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2016
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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