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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER BLADE, SCALPEL

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ASPEN SURGICAL BARD-PARKER BLADE, SCALPEL Back to Search Results
Catalog Number 371111
Device Problems Corroded (1131); Product Quality Problem (1506)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/09/2017
Event Type  malfunction  
Event Description
Bard-parker surgical blades have corrosive area on blade once exposed to fluids. The color of the blade changed to grayish-black. Blade was in acs vascular pack. Staff and surgeons state that other blades have had this also - in sterilized surgical packs and from individual packages from shelf.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE, SCALPEL
Manufacturer (Section D)
ASPEN SURGICAL
1069 state route 46 east
batesville IN 47006
MDR Report Key6993348
MDR Text Key90805294
Report Number6993348
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 10/25/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/01/2017
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number371111
Device Lot Number0127507
Other Device ID Number#11 CARBON RIB-BACK
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/25/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer10/25/2017
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

Patient Treatment Data
Date Received: 11/01/2017 Patient Sequence Number: 1
Treatment
FLUIDS THAT MAY HAVE CONTRIBUTED TO RUST FORMATION; OTHER, FLUIDS
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