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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL, INC. BARD-PARKER STAINLESS STEEL BLADE #10 BLADE, SCALPEL

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ASPEN SURGICAL, INC. BARD-PARKER STAINLESS STEEL BLADE #10 BLADE, SCALPEL Back to Search Results
Device Problem Difficult to Open or Remove Packaging Material (2922)
Patient Problem No Information (3190)
Event Date 03/25/2019
Event Type  malfunction  
Event Description
The 10 blade in it's bard-parker original packaging is contained in one of our surgical packs. When the scrub nurse began peeling open the outer metal packaging, the inner paper packaging over blade did not peel back on either side to expose the blade. Blade with packaging passed off sterile field and additional bard parker 10 blade obtained from supply cart and opened on sterile field. Staff reported the same event on prior procedure but the scrub used heavy scissors to cut blade out of packaging.
 
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Brand NameBARD-PARKER STAINLESS STEEL BLADE #10
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL, INC.
6945 southbelt drive se
caledonia MI 49316
MDR Report Key8514336
MDR Text Key141953595
Report Number8514336
Device Sequence Number1
Product Code GES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2019
Event Location Hospital
Date Report to Manufacturer04/15/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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