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

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.

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.

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.I have attached the letter issued to roi cps, llc from aspen surgical.This was received as a response from aspen after roi cps, llc submitted a complaint to aspen.

• Brand Name: BARD-PARKER
• Type of Device: BLADE SURG RIB BCK CARB 10
• Manufacturer (Section D): ASPEN SURGICAL; caledonia, mi
• MDR Report Key: 10403414
• MDR Text Key: 206535746
• Report Number: 3014527682-2020-00009
• 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: 08/13/2020

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: 08/07/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/07/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1