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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 Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
The dull aspen blade is not manufactured by roi cps, llc. The blade is purchased from bard-parker (aspen surgical) and is then placed in the roi cps, llc custom procedure tray. Roi has notified the blade manufacturer (aspen surgical) of the event and of this report.
 
Event Description
Discovered during procedure. Minimal delay to case and no harm to the patient as there was no patient contact. No. 10 blades in peripheral vascular packs were dull. The dull blades were contained within roi cps, llc custom pack 80001801, lot 79730j.
 
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Brand NameBARD-PARKER
Type of DeviceBLADE SURG RIB BCK CARB 10
Manufacturer (Section D)
ASPEN SURGICAL
caledonia, mi
Manufacturer Contact
cheyenne stewart
3000 east sawyer road
republic, mo 
7303937
MDR Report Key10403414
MDR Text Key206535746
Report Number3014527682-2020-00009
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/13/2020
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 Received08/07/2020
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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