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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 10, STERILE BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 10, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371210-150
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/09/2018
Event Type  Injury  
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that bard-parker blade broke while in use during a procedure. The incident occurred at the user facility. No sample was available for evaluation. Photographic evidence and manufacturing lot number was provided for review. During a procedure, the blades broke upon initial incision into the deep layer tissue at the beginning of the case; two blades broke in half. Additional new blades were obtained. All pieces were immediately retrieved from the patient. No additional treatment was required for the patient. 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 during surgery process could also cause blade condition. 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. Based on this information, no further action is required.
 
Event Description
Aspen surgical received a report from the distributor indicating that a bard-parker blade broke during a procedure. 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 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 Key7611465
MDR Text Key111402984
Report Number1836161-2018-00069
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 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number371210-150
Device Lot Number0146645
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 Received05/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/18/2018 Patient Sequence Number: 1
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