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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER RIB-BACK SURGICAL BLADE, CARBON STEEL

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ASPEN SURGICAL BARD-PARKER RIB-BACK SURGICAL BLADE, CARBON STEEL Back to Search Results
Catalog Number 371111
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/04/2018
Event Type  malfunction  
Event Description
A bard-parker, size 11 blade broke off in the soft tissue of the patient's operative shoulder at incision. The sharp, broken piece was retrieved from the shoulder joint by the surgeon. No harm came to the patient, as the blade piece was easily retrieved. The blade was saved for return to the manufacturer, and a photograph will be attached to this report. Two outer packages were saved, as it is unclear which package this blade came out of. There are two possible lot numbers it could be. Site reporter will return the blade for failure analysis.
 
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Brand NameBARD-PARKER RIB-BACK
Type of DeviceSURGICAL BLADE, CARBON STEEL
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt dr se
caledonia MI 49316
MDR Report Key7233537
MDR Text Key98764618
Report Number7233537
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 01/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number371111
Device Lot Number0075056 OR 0129158
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2018
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer01/30/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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