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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK CARB 10

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ASPEN SURGICAL BARD-PARKER BLADE SURG RIB BCK CARB 10 Back to Search Results
Model Number 371110
Device Problem Dull, Blunt (2407)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The bard-parker (aspen surgical) blades are not manufactured by roi cps, llc but are purchased from aspen and are then placed in custom procedure kits. The blade manufacture aspen surgical has been notified of the event and of this report.
 
Event Description
Discovered during procedure. No delay in case, no harm to patient, but there was patient contact. 10 blades in at least 10 pacemaker packs were dull. The dull blades are not manufactured by roi cps, llc but were contained within roi cps, llc custom pack 880010, lot 78327o and 77144o.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE SURG RIB BCK CARB 10
Manufacturer (Section D)
ASPEN SURGICAL
6945 southbelt dr
caledonia, mi
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, mo 
7303937
MDR Report Key10404127
MDR Text Key204931490
Report Number3014527682-2020-00010
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
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number371110
Device Lot Number0209336
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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