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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 15, STERILE BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER STAINLESS STEEL BLADES SIZE 15, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 371215-150
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2019
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that a bard-parker blade was discovered with a seal issue found by the end user. No injury or death was reported. A manufacturing lot number was available for review. A review of the dhr was completed and determined there were no non-conformance's related to the reported issue. The most probable root cause for the condition could be machine related if the set-up foil is not installed appropriately. Worn transfer bars and mechanical issues, may also result in the reported issue. Packaging process has established controls to mitigate the reported condition, including functional pull tests of the packaging for integrity. The following controls are in place to mitigate the packaging condition: functional testing, temperature control alarms, in process inspections. Additionally, the ifu which is received with the product, along with the pouch label, identifies this failure mode with the symbol "do not use if package is damaged". This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised. Based on this information, no further action is required. Device not returned.
 
Event Description
Aspen surgical received a report from the distributor indicating that a bard-parker blade was discovered with a seal issue by the end user. No injury or death was reported. This report was filed in our complaint handling system as complaint (b)(4).
 
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Brand NameBARD-PARKER STAINLESS STEEL 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 Key8518188
MDR Text Key145775045
Report Number1836161-2019-00036
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 03/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371215-150
Device Lot Number0171676
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/19/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/15/2018
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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