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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 11, STERILE BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 11, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371111-150
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/04/2018
Event Type  Injury  
Manufacturer Narrative
Aspen surgical received a report from the end user of a bard-parker blade that broke during a procedure which was reported to the fda. The medwatch report for this incident was provided to aspen surgical. In this report, the end user indicated that a sample was available for evaluation and the manufacturing lot number was provided for review. During an arthroscopy shoulder surgery, a bard parker size 11 blade broke off in the soft tissue of the patient. The surgeon removed the broken blade in its entirety without incident. The patient tolerated well and follow up care was not required. Based on the evaluation conducted, lot 0129158 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 (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 is pending return and evaluation. If any additional relevant information is identified following completion of the evaluation, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Aspen surgical received a report from the customer indicating that a bard-parker blade broke off in patient during a procedure. The incident occurred at the user facility. Customer reported two lots (0075056 and 0129158) and was unsure which lot number the broken blade was associated with. Both numbers were filed for investigation this report was filed in our complaint handling system as (b)(4).
 
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Brand NameBARD-PARKER CARBON RIB-BACK 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 Key7297441
MDR Text Key100976015
Report Number1836161-2018-00022
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 Other Health Care Professional
Type of Report Initial
Report Date 01/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number371111-150
Device Lot Number0129158
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2018
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

Patient Treatment Data
Date Received: 02/26/2018 Patient Sequence Number: 1
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