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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER SAFETY BLADES SIZE 10, STERILE BARD-PARKER BLADE

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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER SAFETY BLADES SIZE 10, STERILE BARD-PARKER BLADE Back to Search Results
Model Number 373910-150
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Date 07/19/2019
Event Type  Injury  
Manufacturer Narrative
Aspen surgical received a report from the end user indicating that a bard-parker safety blade cut an employee. Incident occurred at the user facility. No manufacturing lot number was provided for review. End user indicated that a nurse was setting up the or and when placing the blade on the handle, the blade cover did not lock. The blade slid resulting in a laceration below the index finger. The nurse received sutures. Subsequently a hematoma formed and the hand became edematous. The sutures were removed, the area reopened, cleansed and a clot was removed. Nurse is currently recovering from scars and swelling. No manufacturing lot number was provided, therefore a review of the device history record could not be completed. Aspen surgical las piedras site has established controls to mitigate activate protected scalpel condition, including a locked position sensor that inspects one hundred percent prior to packaging. Also, un-shield testing to 10 samples at the beginning of a new lot and every 4 hours is performed until completion of the lot. Additional controls to mitigate this type of condition such as: incoming inspection procedures for handle, and shield, including visual inspection for appearance and dimensional. In-process and quality audits performed, including visual inspection to assure shield is properly assembled. Due to no sample returned and no lot number provided, the root cause cannot be determined. The incident was discussed with set-up personnel regarding incident. No further information is available on the product at this time. Sample not returned. However if any additional relevant information is identified following completion of the sample 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 safety blade cut an employee. Incident occurred at the user facility. This report was filed in our complaint handling system as complaint (b)(4).
 
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Brand NameBARD-PARKER SAFETY 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 Key8892572
MDR Text Key154270368
Report Number1836161-2019-00060
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 07/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number373910-150
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2019
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: 08/14/2019 Patient Sequence Number: 1
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