MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. BARD-PARKER STAINLESS STEEL BLADE SIZE 10, STERILE; SCALPEL BLADE

Model Number 371210

Device Problem Unsealed Device Packaging (1444)

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

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that sterile product was found with a hole in the package.The actual device was not returned for evaluation.Pictures and the manufacturing lot number were provided for review.The most probably root cause is machine related.We expect that temperature variations in the manufacturing and packaging process may have resulted in this package being damaged.This should be treated as the final report, however if any additional relevant information is identified in the future, the additional relevant information will be submitted in a supplemental report.

Event Description

Aspen surgical received a report from our distributor indicating that a scalpel blade was found to have a hole in the back of the package.Photos and lot information were provided for the investigation.No injury or death was reported.This is entered in our complaint system as (b)(4).

• Brand Name: BARD-PARKER STAINLESS STEEL BLADE SIZE 10, STERILE
• Type of Device: SCALPEL BLADE
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 19087850
• MDR Text Key: 340682114
• Report Number: 3002750084-2024-00013
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

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: Other
• Device Model Number: 371210
• Device Lot Number: 0352574
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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