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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371211-150
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2018
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that bard-parker blades are breaking while in use. The incident occurred at the user facility. No injury or deaths were reported. No samples and no photographic evidence were available for evaluation. A lot number was provided for review. Device history record was reviewed for lot number 0151445. No non-conformance's were noted that could be related to the complaint issue. Packaging process has established controls to mitigate broken 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 this condition at aspen surgical (b)(4) site: eat 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. Due to no sample and no photographic evidence available, the condition of the blades could not be confirmed. Based on this information, no further action is required.
 
Event Description
Aspen surgical received a report from the distributor indicating that bard-parker blades are breaking while in use. 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 STAINLESS STEEL BLADES SIZE 11, 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 Key7548795
MDR Text Key109905427
Report Number1836161-2018-00049
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 05/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371211-150
Device Lot Number0151445
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 Received05/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2017
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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