MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE; BLADE, SCALPEL

Model Number 371110-150

Device Problem Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a medwatch form indicating that a single blade pack was opened and the blade was sticking to the packaging so it could not be used.The manufacturing lot number was provided for review.The actual device was not returned for evaluation, and no photographic evidence was provided for review.After investigating, the exact root cause was not identified but there are multiple potential reasons that will be further looked into.

Event Description

Aspen surgical received a medwatch form stating that a single blade pack was opened and the blade was sticking to the packaging so it could not be used.Product was not in use, and there was no harm to the patient.No samples or photos were provided for evaluation.Medwatch form (b)(4).

• Brand Name: BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE
• Type of Device: BLADE, SCALPEL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: terry hall ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 17651325
• MDR Text Key: 322293771
• Report Number: 1836161-2023-00027
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/07/2023

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: 371110-150
• Device Lot Number: 0326499
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1