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 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.

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.

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.Roi cps, llc received a complaint closure letter from the blade manufacturer aspen surgical after submitting a complaint to aspen surgical.

• Brand Name: BARD-PARKER
• Type of Device: BLADE SURG RIB BCK CARB 10
• Manufacturer (Section D): ASPEN SURGICAL; 6945 southbelt dr; caledonia, mi
• MDR Report Key: 10404127
• MDR Text Key: 204931490
• Report Number: 3014527682-2020-00010
• 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: 08/06/2020

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: 08/06/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1