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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD-PARKER / BECTON DICKINSON #11 STAINLESS STEEL SURGICAL BLADE BLADE, SCALPEL

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BARD-PARKER / BECTON DICKINSON #11 STAINLESS STEEL SURGICAL BLADE BLADE, SCALPEL Back to Search Results
Lot Number 0153052
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/28/2018
Event Type  Injury  
Event Description
At the beginning of the left knee arthroscopy with menisectomy surgical procedure, the stainless steel surgical blade broke off in the pt's knee. At the end of the procedure, the surgeon had to make a large incision (2. 5cm) and was able to retrieve the broken piece of the knife blade without any complications.
 
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Brand Name#11 STAINLESS STEEL SURGICAL BLADE
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
BARD-PARKER / BECTON DICKINSON
MDR Report Key7665729
MDR Text Key113396032
Report NumberMW5078255
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 Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number0153052
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/05/2018 Patient Sequence Number: 1
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