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

Model Number 371110

Device Problems Dull, Blunt (2407); Failure to Cut (2587)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2020

Event Type  malfunction  

Event Description

Physician complained that the surgical blade in c-section pack was dull, would not cut through the patient's skin. This occurred eight different times. Patient contact and the procedure was delayed to retrieve new blades from the store room.

• Brand Name: BARD-PARKER
• Type of Device: BLADE SURGICAL RIB BCK CARB 10
• Manufacturer (Section D): ASPEN SURGICAL; caledonia, mi
• Manufacturer (Section G): ROI CPS, LLC; 3000 east sawyer road; republic, mo
• Manufacturer Contact: cheyenne stewart ; 3000 east sawyer road; republic, mo ; 7303937
• MDR Report Key: 10258219
• MDR Text Key: 206188938
• Report Number: 3014527682-2020-00007
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 371110
• Device Lot Number: 0209336
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial