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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER DISPOSABLE SCALPELS SIZE 15, STERILE BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER DISPOSABLE SCALPELS SIZE 15, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371615-100
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/23/2018
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a report from the end user indicating that a bard-parker blade broke when the packaging was opened. Sample is available for return. No photographic evidence was available for evaluation. 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. Also, excessive force applied by end user could also cause blade condition. 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. Sample is pending return to manufacturing site and evaluation. No further information is available on the product at this time. However, 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 end user indicating that a bard-parker blade broke when the packaging was opened. No injury/death was reported. This report was filed in our complaint handling system as complaint (b)(4).
 
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Brand NameBARD-PARKER DISPOSABLE SCALPELS 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 Key7614180
MDR Text Key111903731
Report Number1836161-2018-00072
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 05/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371615-100
Device Lot Number0162270
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 Received05/23/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/03/2017
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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