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.

Manufacturer Narrative

Roi cps, llc received a response letter from the blade manufacturer, aspen surgical.

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
• 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
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 371110
• Device Lot Number: 0209336
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1